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Noteworthy Professional News

Smith, Heather E. PhD, RN, NNP-BC, CNS

Section Editor(s): Eklund, Wakako Minamoto DNP, NNP-BC; ; Smith, Heather E. PhD, RN, NNP-BC, CNS;

doi: 10.1097/ANC.0000000000000662
Noteworthy Professional News
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One Patient Services, Raleigh, North Carolina.

Correspondence: Heather E. Smith, PhD, RN, NNP-BC, CNS, TrialCard, 5150 McCrimmon Parkway, Morrisville, NC 27560 (hsmith@trialcard.com).

QOL Medical, LLC, provides salary for the author.

The author declares no conflict of interest.

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NEWBORN SCREENING

Heather E. Smith, PhD, RN, NNP-BC, CNS

Newborn screening is one of the largest and most successful1 public health initiatives2 and a required test performed on newborns in the United States. This test is the familiar 5 circles requiring blood on filter paper within the first 48 hours of life and then again, closer to discharge, for those infants cared for in the neonatal intensive care unit (NICU). The goal for conducting this test is to identify inheritable disorders early in life to lessen and prevent future sequelae including death.3 The history of this test goes back to the 1960s with the first test assessing for phenylketonuria.3 In nearly 60 years, those eligible for screening would equate to approximately 220 million people in the United States (using 4 million births per year4) with an estimated 5000 infants with a positive finding each year.2 Early detection provides the opportunity at a nominal price ($15 to $150/per test)5 to proactively identify and treat infants before symptoms present, which in turn should decrease an infant's chance of morbidity and mortality and increase their possibility of better life quality for the infant and family.

Progress to a uniform national newborn screening list has been slow. However, the last decade has shown great advances. The selected disorder chosen for testing is state specific even though the state test is federally funded, and several national groups provide guidance for establishing standards.3 One of the major groups is the American College of Medical Genetics (ACMG). The ACMG developed the Recommended Universal Screening Panel in 20053 and continues to update the recommended list that now includes 35 conditions and 26 secondary conditions.5 New legislature called Newborn Screening Saves Lives Act was established in 2008 and allowed for the creation of the Advisory Committee on Heritable Disorders in Newborns and Children to inform the Health and Human Services (HHS) Secretary regarding newborn screening. This legislature creates formal communication to the HHS Secretary for making informed decisions about project funding, establishing testing priorities, and state funding for enhancing states' screening panel, parent education, and continued newborn screening laboratory standards.6 Programs covered by this act will expire at the end of September 2019 without a renewal by Congress.

Do you believe newborn screening is important? Have you seen a child and family benefit from early screening? If you would like to continue support for newborn screening, there is something you can do—write to your member of Congress. You can go down the traditional route of pen and paper or go online. If you need some assistance, the Everylife Foundation has made voicing your support to your Congress member easy. Go to https://everylifefoundation.org/voter-voice/?vvsrc=%2fcampaigns%2f62708%2frespond to find out more.

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ACTIVE NEONATAL DRUG STUDY

There is a very short list of drugs approved for neonatal use by the Federal Drug Administration (FDA).7 Having a company dedicated to neonatal studies with a new drug in the pipeline specifically created for neonates is exciting and rare. The company is called Infant Bacterial Therapeutics (IBT) and they have been working on a new drug they call IBP-9414 for the prevention of necrotizing enterocolitis (NEC).8 IBP-9414 is using the live bacterial strain Lactobacillus reuteri found in human milk to study its impact on reducing the occurrence of NEC in infants born before 32 weeks' gestation9 who are at the most risk for NEC. For a drug to receive FDA approval, an investigational new drug process is required to show various phases (phases I-III) or studies of safety and efficacy data including randomization for the FDA to offer market approval.10 In 2017, IBP-9414 was used in a phase II study at many US NICUs and the results showed IBP-9414 to be well-tolerated and safe. In July 2019, the first subject was enrolled into the phase III study known as the Connection Study. The purpose of the Connection Study is to show that randomized neonates to IBP-9414 have less prevalence of NEC than those neonates given placebo. This study is being conducted internationally and expected to enroll over 2000 infants. If enrollment and outcomes go as expected, IBT expects to submit the data to the FDA in 2021 for FDA market approval.8

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NEW GBS TREATMENT GUIDELINES

The American Academy of Pediatrics (AAP) in conjunction with the American College of Obstetricians and Gynecologists (ACOG) has recently published new guidance for treating group B streptococcal (GBS) infection.11 These new guidelines will replace the last consensus guidelines in 2010. These new guidelines are consistent with recent AAP bacterial causes of early-onset sepsis recommendations and also include how to best manage late-onset GBS and treatment for both early and late-onset GBS. The new recommendations focus on (1) the assessment of early-onset GBS for those greater than and less than 35 weeks' gestation separately, (2) acceptable intrapartum antibiotic prophylaxis (IAP) can be accomplished with penicillin G, ampicillin, or cefazolin for early-onset GBS, but not for clindamycin and vancomycin, (3) blood and cerebrospinal fluid culture are the only 2 laboratory tests to confirm early-onset GBS and that a late-onset GBS diagnosis must have a positive culture from a typically sterile site, and (4) antibiotic treatment will vary based on the infant's postnatal age. To read more details about the new neonatal GBS treatment guidance go to https://pediatrics.aappublications.org/content/early/2019/07/04/peds.2019-1881. If you are interested in understanding ACOG's changes for IAP, notes from the committee's meetings can be found separately online.12

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References

1. Newborn screening: a blueprint for the future executive summary: newborn screening task force report. Pediatrics. 2000;106(2, pt 2):386–388.
2. Baby's First Test. Screening Facts. Newborn Screening. Baby Health. https://www.babysfirsttest.org/newborn-screening/screening-101. Accessed July 8, 2019.
3. NICHD. Brief History of Newborn Screening. http://www.nichd.nih.gov/. http://www.nichd.nih.gov/health/topics/newborn/conditioninfo/history. Accessed July 8, 2019.
4. Centers for Disease Control and Prevention. Newborn Screening Laboratory Bulletin. https://www.cdc.gov/nbslabbulletin/bulletin.html. Published May 29, 2019. Accessed July 8, 2019.
5. EveryLife Foundation for Rare Diseases. Newborn Screening. https://everylifefoundation.org/newborn-screening/. Accessed July 8, 2019.
6. Baby's First Test. Newborn Screening Legislation. Newborn Screening. Baby Health. https://www.babysfirsttest.org/newborn-screening/newborn-screening-legislation. Accessed July 8, 2019.
7. Laughon MM, Avant D, Tripathi N, et al Drug labeling and exposure in neonates. JAMA Pediatr. 2014;168(2):130–136. doi:10.1001/jamapediatrics.2013.4208.
8. Infant Bacterial Therapeutics. IBP-9414. http://ibtherapeutics.com/r-and-d/ibp-9414-dev-program/. Accessed July 8, 2019.
9. ClinicalTrials.gov. IBP-9414 for the Prevention of Necrotizing Enterocolitis. The Connection Study. Full Text View. https://clinicaltrials.gov/ct2/show/NCT03978000. Accessed July 8, 2019.
10. FDA. Step 3: Clinical Research. http://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Published April 2019. Accessed July 8, 2019.
11. Puopolo KM. Early-onset group B strep: new guidance includes changes in dosing, assessment. AAP News. July 2019. https://www.aappublications.org/news/2019/07/08/gbs070819. Accessed July 8, 2019.
12. Prevention of group b streptococcal early-onset disease in newborns: ACOG Committee Opinion, Number 782. Obstet Gynecol. 2019;134(1):e19–e40. doi:10.1097/AOG.0000000000003334.
© 2019 by The National Association of Neonatal Nurses