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

Award Number: R01HL098354
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$1,004,552 )
2025	2021	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	8	11/27/2024	NON-COMPETING CONTINUATION	-$1,004,552
														Subtotal = -$1,004,552

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	8	7/6/2023	NON-COMPETING CONTINUATION	$0
2023	2021	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	001	8	7/13/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	8	7/20/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,795,125 )
2021	2021	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	002	8	9/2/2021	NON-COMPETING CONTINUATION	$1,795,125
2021	2020	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	001	7	6/7/2021	NON-COMPETING CONTINUATION	$0
2021	2020	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	7	5/13/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,795,125

Issue Date FY: 2020 ( Subtotal = $1,919,868 )
2020	2020	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	7	8/21/2020	NON-COMPETING CONTINUATION	$1,919,868
														Subtotal = $1,919,868

Issue Date FY: 2019 ( Subtotal = $1,903,430 )
2019	2019	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	001	6	7/20/2019	NON-COMPETING CONTINUATION	$1,903,430
2019	2017	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	5	4/11/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,903,430

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2017	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	5	8/17/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $1,905,634 )
2017	2017	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Lung Diseases Research	000	5	8/28/2017	NON-COMPETING CONTINUATION	$1,905,634
														Subtotal = $1,905,634

Issue Date FY: 2016 ( Subtotal = $1,903,799 )
2016	2016	GEORGE WASHINGTON UNIVERSITY	44983 KNOLL SQUARE	ASHBURN	VA	20147	LOUDOUN	USA	Lung Diseases Research	000	4	9/3/2016	COMPETING CONTINUATION	$1,903,799
														Subtotal = $1,903,799

Grand Total All Awards = $8,423,304

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

Award Number: R01HL098354

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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