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A Prospective Randomized Controlled Trial to Evaluate the Impact of Treatment of Asymptomatic Bacteriuria on Low Birth Weight

Award Number: U01HD115569
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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A Prospective Randomized Controlled Trial to Evaluate the Impact of Treatment of Asymptomatic Bacteriuria on Low Birth Weight - PROJECT SUMMARY/ABSTRACT Asymptomatic bacteriuria (AB) in pregnancy has been associated with an increased incidence of neonatal morbidity including preterm birth and low birth weight (LBW) and maternal morbidity including pyelonephritis. Hypothesis: Treatment of pregnant individuals with AB will reduce the incidence of newborns with LBW in low- and middle-income countries (LMICs). Significance: LBW occurs in more than 20 million newborns each year globally and is associated with an increased risk of neonatal death and lifetime morbidity. This proposal will examine the impact of treating AB in pregnant individuals in LMICs on the incidence of LBW and serious maternal and neonatal morbidity. Investigators: Dr. Chisholm (mPI) is an academic maternal-fetal medicine subspecialist with 5 years of experience as a member of the NICHD Global Network for Women’s and Children’s Health Research (GN) and investigator in global clinical trials. Dr. McClure (mPI) is a perinatal epidemiologist and PI of the Data Coordinating Center who has more than 20 years of experience contributing to the leadership of the GN and overseeing research in LMICs. Co-Is Dr. Petri at the University of Virginia and Dr. Haque at the International Centre for Diarrheal Disease Research, Bangladesh, have collaborated for 30 years on maternal–child health and infectious diseases research. Innovation: The proposed study will address calls from the World Health Organization, USPSTF, and numerous professional societies for data evaluating the impact of treatment for AB in contemporary obstetric populations in LMICs where the burden of LBW and associated neonatal morbidity is highest and where the practice of screening for AB is less widely implemented. Approach: We will conduct a randomized, double-blind, placebo-controlled parallel-arm trial to address the following specific aims: Specific Aim 1: Test the primary outcome of the trial, which is the impact of antibiotic (nitrofurantoin) treatment of AB on LBW. This will be done by comparing the incidence of LBW between those randomized to receive nitrofurantoin and those randomized to receive placebo. Specific Aim 2: Test the secondary outcome of the trial, which is the impact of antibiotic treatment of AB on serious maternal morbidity in pregnancy. This will be done by comparing maternal morbidity between those randomized to receive nitrofurantoin and those randomized to receive placebo. We hypothesize that treatment of AB in pregnancy will reduce the incidence of pyelonephritis and pre-eclampsia.


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: 2026 ( Subtotal = $0 )
2026	2025	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	2	12/17/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $1,100,885 )
2025	2025	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	2	8/22/2025	NON-COMPETING CONTINUATION	$1,100,885
2025	2025	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	2	9/11/2025	NON-COMPETING CONTINUATION	$0
2025	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	8/21/2025	NEW	$0
														Subtotal = $1,100,885

Issue Date FY: 2024 ( Subtotal = $828,321 )
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	9/20/2024	NEW	$828,321
														Subtotal = $828,321

Grand Total All Awards = $1,929,206

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A Prospective Randomized Controlled Trial to Evaluate the Impact of Treatment of Asymptomatic Bacteriuria on Low Birth Weight

Award Number: U01HD115569

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/20/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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