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

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2020 · $1

## 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:** 9977250
- **Project number:** 5R01HL098554-08
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** CYNTHIA GYAMFI-BANNERMAN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1
- **Award type:** 5
- **Project period:** 2010-08-05 → 2021-06-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9977250

## Citation

> US National Institutes of Health, RePORTER application 9977250, Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study - Clinical Coordinating Center (ALPS-FS: CCC) (5R01HL098554-08). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9977250. Licensed CC0.

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