# Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study - Data Coordinating Center (ALPS FS - DCC)

> **NIH NIH R01** · GEORGE WASHINGTON UNIVERSITY · 2020 · $1,919,868

## Abstract

Project Summary/Abstract
In the past, medical tenets held that premature infants born “late preterm” between 34 and 36
weeks have negligible neonatal complications with long term prospects essentially the same
as those born at term (at 37 weeks or later). It is now recognized that late preterm infants are at
increased risk for death and serious neonatal respiratory morbidity including respiratory distress
syndrome and bronchopulmonary dysplasia, in addition to other adverse outcomes. Since three
fourths of preterm births occur in the late preterm period, this is a significant public health
problem. To address this issue, the NICHD Maternal-Fetal Medicine Units (MFMU) Network
recently completed the Antenatal Late Preterm Steroids (ALPS) trial where women at risk for
late preterm delivery were randomized to betamethasone, a therapy that is standard of care for
improving neonatal respiratory and other outcome at earlier gestations, or placebo. The ALPS
trial showed a significant decrease in neonatal respiratory morbidity. These notable findings will
change practice in obstetrics, and understanding the long-term implications of this therapy is
paramount. Moreover, little information on long-term pulmonary outcomes of children born in
the late preterm period are published, and no statistics on the effects of antenatal
betamathasone exposure in this population exists. These data are critical to understand the
results of ALPS as well as to provide much needed information regarding childhood sequelae of
late preterm birth.
This application entitled “Pulmonary Complications in a Birth Cohort after a Randomized Trial of
Antenatal Corticosteroids: the ALPS Follow-Up Study” (ALPS-FS) describes a prospective
follow-up of the ALPS trial to test the following hypotheses: 1) childhood chronic lung disease is
lower in those exposed to betamethasone compared with placebo, 2) childhood chronic lung
disease varies by gestational age at delivery from 34 to 40 weeks, and 3) various obstetric
conditions such as preeclampsia and growth restriction are risk factors for childhood chronic
lung disease, after accounting for gestational age at birth. Children whose mothers were
enrolled in ALPS will have pulmonary function testing in addition to a comprehensive
assessment of respiratory illness via questionnaire and medical records. Prospective
respiratory symptomatology will be ascertained via text messaging for a period of one year.
Children born to low risk women enrolled in a concurrent MFMU trial will serve as term controls

## Key facts

- **NIH application ID:** 9981484
- **Project number:** 5R01HL098354-07
- **Recipient organization:** GEORGE WASHINGTON UNIVERSITY
- **Principal Investigator:** Rebecca Gersnoviez Clifton
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,919,868
- **Award type:** 5
- **Project period:** 2010-08-05 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9981484

## Citation

> US National Institutes of Health, RePORTER application 9981484, Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study - Data Coordinating Center (ALPS FS - DCC) (5R01HL098354-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9981484. Licensed CC0.

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