# 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** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2020 · $165,655

## 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:** 10511115
- **Project number:** 7R01HL098554-09
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** CYNTHIA GYAMFI-BANNERMAN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $165,655
- **Award type:** 7
- **Project period:** 2010-08-05 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10511115

## Citation

> US National Institutes of Health, RePORTER application 10511115, Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study - Clinical Coordinating Center (ALPS-FS: CCC) (7R01HL098554-09). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10511115. Licensed CC0.

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