Preterm infants are one of the most vulnerable patient populations. Prematurity is the second leading cause of death among infants in the United States.1 Over half of all infant deaths occur in preterm infants born at less than 32 weeks' gestation, and the infant mortality rate for this population is 88 times that of the rate for full-term infants.2 This population is prone to heat loss, hypoglycemia, and infection after birth.3–6
Preterm infants are at increased risk of hypothermia due to their limited ability to initiate nonshivering thermogenesis, limited ability for peripheral vasoconstriction, and increased evaporative heat loss via transepidermal water loss through immature skin.7 Moderate hypothermia at admission in very low birth-weight infants is associated with higher mortality compared with normothermic infants.8 An admission temperature of less than 36°C is associated with a 64% increase in the risk of early neonatal death.8
Preterm infants are at increased risk of hypoglycemia due to decreased glycogen stores, leading to a decreased ability to produce glucose.9 Preterm infants are also likely to have increased metabolic demands due to stress, respiratory distress syndrome, hypoxia, and other factors, thus leading to increased glucose utilization.10 While term infants usually feed within an hour of birth, preterm infants must rely on glucose-containing intravenous (IV) fluids to maintain adequate blood glucose levels after birth.
Preterm infants have a 3 to 10 times higher likelihood of developing infection compared with term infants.11 Group B streptococcus and Escherichia coli remain the most common causes of early-onset sepsis in preterm, very low birth-weight infants.12 Preterm infants have immature innate and adaptive immunity, placing them at increased risk for infection.6 Early-onset sepsis leads to death in 11% of infants affected and 6.3% of survivors experience sequelae at discharge, including hearing loss, seizures, and oxygen requirement.13 Strategies should be identified and implemented to minimize the effects of these problems and improve outcomes in this fragile population.
The Golden Hour protocol provides a guide for caring for preterm infants at birth in a systematic manner.14–17 The protocol includes interventions focused on delivery room resuscitation, respiratory stabilization, thermoregulation, early initiation of antibiotics, and early initiation of IV fluids and nutrition.18 Other published Golden Hour studies included variations of this protocol based on the specific needs of the unit.14–17 Implementing an evidence-based Golden Hour protocol with defined roles for each team member has shown to increase neonatal intensive care unit (NICU) staff efficiency and organization, which led to improved patient outcomes.14
In the NICU at a large military medical center, the admission process for preterm infants took up to 2 hours to complete. Delays in the initiation of glucose-containing IV fluids and empiric IV antibiotics often occurred due to multiple factors, including delays in placement and x-ray verification of umbilical lines, and delays in receiving antibiotics from the pharmacy. Radiology was responsible for taking radiographs for patients housed over the entire hospital, and the timing of a stat radiograph would vary depending on the patient acuity and census of the rest of the hospital. Patient administration delays in admitting the infant in the electronic medical record led to delays in writing orders for fluids and antibiotics. There was a lack of consistency in the timing of interventions, such as placement of umbilical lines, during the admission process. In some instances, placement of umbilical lines occurred once an infant arrived in the NICU, and other times this procedure occurred later in the admission process.
EVIDENCE FOR INTERVENTION
One goal of the Golden Hour protocol is to prevent hypothermia. Neonatal Resuscitation Program recommendations for preterm infants less than 32 weeks' gestation include increasing the delivery room temperature to 23°C to 25°C, placing the infant on a thermal mattress, placing a hat on the infant's head, and wrapping the infant in a polyethylene plastic bag.19 Each of these interventions is included in the Golden Hour protocol. Three randomized controlled trials confirmed that the use of occlusive plastic wrap for preterm infants at birth improved admission temperature compared with no plastic wrap.4,20,21 In one study, infants placed in plastic wrap upon delivery had a significantly higher mean admission temperature compared with infants in the control group (36.5°C vs 36.0°C; P < .003).4 Similarly, another study found that infants placed in plastic wrap upon delivery had a significantly higher mean admission temperature compared with those not placed in plastic wrap (36.26°C vs 35.79°C; P = .004).21 The incidence of adverse outcomes in one study, including neurological injury, retinopathy of prematurity, and necrotizing enterocolitis, was lower in infants with admission temperatures between 36.5°C and 37.2°C.22 The protocol also aims to close the incubator top within 1 hour of birth. The use of a humidified incubator has been shown to improve thermoregulation and reduce insensible water loss in preterm infants.23
The Golden Hour protocol also aims to improve time to initiation of glucose-containing IV fluids and prevent hypoglycemia in the target population. Blood glucose in preterm infants reaches a nadir between 30 and 90 minutes after birth.24 It is imperative that glucose-containing IV fluids be initiated quickly in this patient population. Glucose measures in preterm infants have improved on admission in 2 study reports due to implementation of a Golden Hour protocol.15,16 Time to initiation of dextrose IV fluids was also improved through implementation of Golden Hour protocols in published studies.15,16 Implementation of a Golden Hour protocol in one study showed a statistically significant increase in infants with an admission glucose greater than 50 mg/dL from pre- to postimplementation (55.7% vs 72%; P = .012) as well as a statistically significant increase in initiation of glucose-containing IV fluids within 1 hour of life (61.3% vs 7%; P = .001).15
One additional aim of the Golden Hour protocol is to improve time to initiation of empiric antibiotics when indicated. The American Academy of Pediatrics (AAP) recommends that every critically ill infant needs evaluation for sepsis and treatment with broad-spectrum antibiotics.25 The AAP recommends ampicillin plus an aminoglycoside, most often gentamicin, for empiric coverage for the most common early-onset sepsis pathogens.25 The Surviving Sepsis Campaign (SCC) is a collaboration of international critical care experts aimed at decreasing morbidity and mortality related to sepsis and septic shock.26 SSC guidelines recommend initiation of empiric broad-spectrum antimicrobial therapy as soon as possible and within 1 hour when sepsis is suspected.26 Delay in initiation of antibiotics in cases of suspected sepsis is associated with an increase in mortality.26 Researchers showed improved time to initiation of antibiotics by an average of 60 minutes in 1 Golden Hour project.16
The objective of this project was to improve patient outcomes by implementing an evidence-based Golden Hour protocol for stabilization and admission of preterm infants born at less than 32 weeks' gestation, customized for the institution.
The aims of this project were:
- To increase the percentage of infants who had an axillary temperature of 36.5°C or greater within 1 hour of birth from preimplementation to postimplementation.
- To decrease time to initiation of glucose-containing IV fluids from preimplementation to postimplementation.
- To decrease time to administration of antibiotics from preimplementation to postimplementation.
- To close the incubator top within 1 hour of birth postimplementation.
The setting for this project was a 25-bed level III NICU at a large military medical center. The patient population in this unit includes preterm and term infants who are dependents of active duty or retired military members covered by Tricare. An average of 25 infants per month require admission to the NICU, and of those, approximately 5 infants are less than 32 weeks' gestation at birth. The NICU is staffed by neonatologists, neonatal fellows, medical residents, nurses, and administrative support staff. Staffing consists of a mix of both civilian and military members.
A convenience sample of preterm infants born at less than 32 weeks' gestation was used for this quality improvement project. Gestational age was determined by the maternal estimated date of confinement documented in the electronic medical record. Inclusion criteria included gestational age of less than 32 weeks' gestation at birth and born at the medical center. Exclusion criteria included infants born at outlying facilities and transferred to the medical center after birth and infants born at 32 weeks' gestation and greater.
A Golden Hour protocol was designed for this project based on evidence from the literature and customized according to feedback from key staff members to make it appropriate for the institution. During the planning phase of the project, interviews of staff members provided insight into current practices and provided input into the development of the project. These staff members included the NICU clinical nurse specialist (CNS), chief neonatologist, neonatology fellow, charge nurses, and members of the NICU Unit Practice Council (UPC). Multidisciplinary team members from pharmacy, patient administration, and radiology also provided feedback.
The project team gave the staff and multidisciplinary team members the education component of the Golden Hour protocol via a PowerPoint presentation by e-mail, followed by in-person training in the NICU. The in-person training followed the same PowerPoint presentation that was e-mailed to staff and provided detailed review of the Golden Hour team member roles chart (Figure 1) and NICU admission worksheet (Figure 2). Additional training of nurses and respiratory therapists included face-to-face meetings during their shifts at which time protocol-related questions were addressed. The charge nurses played a large role in the protocol and all charge nurses received the in-person training. Supportive evidentiary literature provided to clinicians showed the positive patient outcomes that resulted from implementing Golden Hour protocols in the NICU setting. Attending physicians, fellows, and residents were trained during one of the weekly fellow conferences. A follow-up e-mail sent to all clinicians reminded them of the start date and key points regarding the protocol. The education phase took 2 weeks to complete and 70% of staff members were reached in person.
Once the education phase was completed, the protocol was implemented. The first part of the protocol was a prehuddle prior to delivery. During this time, team members involved in the care during the first hour of life reviewed pertinent maternal and prenatal history, reviewed the roles for each team member outlined on the team member roles chart (Figure 1), and checked equipment in the delivery room. Once the infant was delivered, team members worked together performing their assigned roles providing the interventions outlined in the protocol. Thermoregulation interventions included placing the infant in occlusive plastic wrap and placing the infant on a thermal mattress under the warmer. The infant was transferred to the NICU where a peripheral IV catheter and/or umbilical catheter(s) were placed and glucose-containing IV fluids were initiated, along with the initiation of antibiotics if needed. An axillary temperature was taken upon admission to the NICU and again at 1 hour of life. To ensure all steps of the Golden Hour protocol were completed, a nurse recorder collected the data for the NICU admission worksheet (Figure 2) in the delivery room and upon transfer to the NICU. The nurse recorder also acted as a timekeeper to keep the team on track and ensure accurate data collection to meet the goal of achieving infant stabilization, maintaining a normothermic state, initiation of IV fluids and antibiotics, and closing the top of the incubator within 1 hour of life. All clinicians involved in the delivery and stabilization process met in a posthuddle after completion of the admission to review successes and areas of improvement for future admissions.
Assessment and Measures
A pre-/postdesign was used to compare outcomes for preterm infants prior to and after implementation of the Golden Hour protocol. Preimplementation data were collected by retrospective chart review via the electronic medical record of all infants born at less than 32 weeks' gestation at the hospital during the 6 months prior to the project implementation date. Postimplementation data were collected from the NICU admission worksheets filled out by the nurse recorder of all eligible infants born during the 3 months after implementation. Table 1 shows the measures used to evaluate the project outcomes.
TABLE 1. -
||Axillary temperature taken upon admission to the NICU and at 1 h of life
|Time to initiation of glucose-containing IV fluids
||Time to initiation of D10W or starter TPN in minutes
|Time to administration of antibiotics
||Time to administration of ampicillin and gentamicin in minutes
|Time to close of incubator top
||Time to close of incubator top in minutes
Abbreviations: D10W, 10% dextrose in water; IV, intravenous; NICU, neonatal intensive care unit; TPN, total parenteral nutrition
Descriptive statistics were obtained for the frequency and percentage for gender and mean and standard deviation for gestational age and birth weight at pre- and postimplementation. To examine Aim 1, a Fisher's exact test was performed to compare pre- and postimplementation on the percentage of infants with a temperature of 36.5°C or greater within 1 hour of birth. Independent samples t tests were used to compare the time to initiation of IV fluids and time to administration of antibiotics between pre- and postimplementation (Aims 2 and 3). Descriptive statistics were used to describe frequency and percentage of infants with the incubator top closed within 1 hour of birth postimplementation (Aim 4). Data were analyzed using IBM SPSS version 24, with an α set to .05.
The sample included 24 infants, with 17 in the preimplementation group and 7 in the postimplementation group. There were no significant differences between the 2 groups in regard to gestational age, weight, or gender (Table 2).
TABLE 2. -
|Gestational age, mean (SD), range, wk
||29.1 (2.6), 24.57-31.71
||29.1 (2.8), 24.14-31.43
|Birth weight, mean (SD), g
0-500 g, n (%)
500-750 g, n (%)
750-1000 g, n (%)
1000-1250 g, n (%)
1250-1800 g, n (%)
|Gender, n (%)
||Male: 9 (53)
Female: 8 (47)
|Male: 3 (43)
Female: 4 (57)
Abbreviation: SD, standard deviation.
Table 3 displays the results for clinical measure comparisons between the pre- and postimplementation groups. There was an increase in the percentage of infants with a temperature of 36.5°C or greater within 1 hour of life from preimplementation (n = 13, 76.5%) to postimplementation (n = 7, 100%). Regarding initiation of IV fluids, the average time decreased from 67.1 minutes preimplementation to 44.1 minutes postimplementation. The average time to administration of ampicillin decreased from 111.2 minutes preimplementation to 96.6 minutes postimplementation. A decrease in average time to administration of gentamicin was also seen, from 154.1 minutes preimplementation to 127.1 minutes postimplementation. The average time to closure of the incubator top was 153 minutes, which showed none of the postimplementation incubator closures was within 1 hour of life.
|Temperature >36.5°C by 1 h, n (%)
|Time to IV fluids, mean (SD), min
|Time to antibiotics, mean (SD), min
||Amp: 111.2 (72.2)
Gent: 154.1 (76.4)
|Amp: 96.6 (29)
Gent: 127.1 (19.8)
|Time to close of incubator, top, mean (SD), min
Abbreviations: Amp, ampicillin; Gent, gentamicin; IV, intravenous; SD, standard deviation.
The purpose of this project was to improve outcomes related to hypothermia, hypoglycemia, and early-onset sepsis by increasing the efficiency of the stabilization and admission process of preterm infants born at less than 32 weeks' gestation. While analyses of outcomes were not statistically significant, there were improvements in axillary temperature, time to initiation of IV fluids, and time to initiation of antibiotics. These improvements were clinically significant and showed a trend toward an overall decrease in time to completion of the admission process.
The percentage of infants with an axillary temperature of 36.5°C or greater by 1 hour of life increased to 100% postimplementation; however, 2 of these infants were hyperthermic, with temperatures of 37.7°C and 37.9°C at 1 hour of life. While the exact reason for the hyperthermia in these cases is unknown, it may have been due to insufficient placement of the temperature probe or failing to switch the incubator to servo mode. Ensuring staff members are aware of the dangers of hyperthermia may aid in maintaining infant temperatures in range. Aiming for a temperature range of 36.5°C to 37.2°C during admission has been shown to decrease adverse outcomes.22
The time to initiation of glucose-containing IV fluids decreased by an average of 23 minutes from preimplementation to postimplementation. Nurses placed peripheral IVs quickly and were able to start 10% dextrose in water (D10W) upon arrival of infants to the NICU. D10W was a stocked fluid in the NICU Pyxis medication station, so nurses only required the order.
The average time to administration of both ampicillin and gentamicin decreased by 14.6 and 27 minutes, respectively, from preimplementation to postimplementation. At this military medical center NICU, ampicillin was a standard stocked item in the Pyxis medication station in the NICU; however, gentamicin was a pharmacy-generated medication. The larger decrease in time to administration of gentamicin can be attributed to pharmacy staff awareness of the Golden Hour protocol.
The axillary temperature was consistently greater than 36.5°C through 1 hour of life for all infants postimplementation, even with the incubator top open. While it is important to close the incubator top to provide humidity, this step may not be as critical as other components of the protocol, as thermoregulation did not appear to be affected during the first hour with the top open.
Involvement of key stakeholders and end users of the protocol was critical in this project. The NICU CNS, NICU Service Chief and Assistant Service Chief, chief neonatologist, neonatology fellow, charge nurses, and the UPC were involved in the planning and implementation of the project and provided valuable insight into current practices on the unit and identification of possible barriers to implementation. The stakeholders were directly involved in the development of the team member roles chart (Figure 1) and NICU admission worksheet (Figure 2).
One unique aspect of military medical centers is the regular turnover of staff members. This turnover is a result of Permanent Change of Station moves that occur every 3 years and often makes implementing change difficult. In the NICU, this leads to variation in practices among physicians and nurses based on experiences on other units. The Golden Hour protocol provided a way to standardize the stabilization and admission process in the NICU so that it remained the same despite staff turnover. Based on the findings of this project, it is recommended that other military institutions implement Golden Hour protocols to standardize stabilization procedures and collect data to document changes in infant outcomes related to this protocol.
Staff members identified several barriers to completing the Golden Hour protocol within 1 hour of life. Placement of umbilical lines often delayed the time to initiation of antibiotics and time to close of the incubator top. According to standard of care in this NICU, blood cultures should be obtained from the umbilical line at the time of placement and before starting antibiotics. The incubator top cannot be closed until the lines are placed. Factors that caused a delay in placement of umbilical lines included need for intubation and/or surfactant administration and training of medical residents to place umbilical lines. Another barrier to completion of the protocol by 1 hour of life was a delay in receiving gentamicin from pharmacy. In one instance, the wrong antibiotic order was entered initially and correction of this resulted in a delay. In another instance, pharmacy was unable to send gentamicin within the designated time. While the time to administration of antibiotics did improve from baseline, there is still a need for improvement to get antibiotics started within the first hour of life. Consistent use of the paper stat order form or the use of standard admission orders that have basic consistent requirements may improve the timing of antibiotic administration. Providers can fill out this form and send it to the pharmacy as soon as the infant is admitted to expedite antibiotic delivery. Decreasing the time to placement of umbilical lines and collection of the blood culture can also improve the time to administration of antibiotics. More education to providers on potential outcomes related to delayed administration of antibiotics may also improve the time to initiation of antibiotics. Allowing the pharmacists to initiate antibiotics orders, when indicated, based on birth weight and gestational age improved the time to initiation of antibiotics in 1 published Golden Hour study.16
Relation to Other Evidence
Previous published quality improvement projects demonstrated the successful implementation of a Golden Hour protocol.14–17 The protocols used in these projects varied based on the unique needs of the specific unit involved. Previous studies showed an improvement in admission temperature after implementation of a Golden Hour protocol.15–17 Thermoregulation interventions in these studies focused on increasing the delivery room temperature, placing the infant in a plastic wrap, and placing the infant on a thermal mattress, which were used in this project as well. As found in the present project, one study noted cases of hyperthermia as an unintended result of the protocol.16 Hyperthermia has been shown to increase adverse outcomes in preterm infants22; therefore, the use of a goal temperature range may prevent the occurrence of hyperthermia in this patient population.15
Clinicians have also showed improvement in the time to initiation of IV fluids after implementation in published Golden Hour projects.15–17 One study included placement of umbilical lines in the resuscitation area prior to transfer to the NICU, which contributed to the success of placing umbilical lines and initiating IV fluids early.15 In another study, pharmacists were allowed to initiate antibiotic orders, when indicated, leading to a decreased time to initiation of antibiotics.16 While this project did not have statistically significant results like those presented in the previously published Golden Hour studies, there was a clinically significant decrease in time to initiation of IV fluids and antibiotics.
Each of the previously published Golden Hour studies had a larger sample size. These studies took place in large NICUs with 56 to 82 beds and collected data over a 1- to 3-year period.15–17 In comparison, the present study took place in a 25-bed NICU, with preimplementation data collection over 6 months and postimplementation data collection over 3 months. The setting and longer data collection periods of the previous studies contributed to a larger sample size. One study used simulation to train staff members on their Golden Hour protocol.17 Simulation may have been beneficial in the present study due to the low volume of deliveries of infants less than 32 weeks' gestation. This may have made staff more familiar with the protocol.
One limitation of this project was the small sample size due to the short study period and the lower than average patient census in the NICU. Another limitation was that only 70% of staff members were able to be reached during in-person training. Most of the staff members who were not reached in-person were part-time contract nurses who work minimal hours. Lack of this training could have led to confusion during Golden Hour admissions for these part-time nurses.
Implications for Practice
Implementation of a Golden Hour protocol provides staff members with a guide to providing care to preterm infants during the first hour of life, which has been shown to improve outcomes in this patient population. The development of similar protocols in other NICUs must address the components specific to the unit. For example, the delivery team for the NICU in this project consisted of a physician, the charge nurse, a respiratory therapist, an admission nurse, and a recorder. Other NICUs may have different staff members who attend deliveries, such as neonatal nurse practitioners, and their protocol should reflect this. Protocols should address the main issues identified specific to the setting. For example, in this project, timing of antibiotic administration was identified as an issue. Other NICUs may have a dedicated NICU pharmacy and may not have this same issue.
Key stakeholders and end users should be involved throughout the planning of the project. These staff members can provide valuable insight into current practice and identification of possible barriers to implementation. Staff education is key to the success of implementation of a Golden Hour protocol. Staff members must understand the importance of the intervention and become familiar with the steps of the protocol. In military institutions, implementing a Golden Hour protocol can standardize practice despite high staff turnover rates.
In this quality improvement project, impressive strides toward the implementation of a Golden Hour protocol were made to improve the admission and stabilization process for preterm infants. Providing efficient, evidence-based care in the first hour of life has the potential to improve outcomes in this patient population. Even small improvements in care can contribute to positive outcomes for preterm infants. Quality improvement initiatives in the NICU setting must continue to be supported to provide the best possible start for our most vulnerable patients.
Special thanks to Julie Thompson and the staff of the NICU at Walter Reed National Military Medical Center for their contributions to this project and commitment to quality improvement.
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