RFP Announcement: Respiratory Distress in Newborns and Its Relationship to Group B Streptococcal Colonization

Notice Number: NOT-HD-07-007

Key Dates
Release Date: December 1, 2006
Receipt Date:  February 14, 2007

Issued by
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), has a need for clinical centers to participate in a clinical study relating respiratory distress in newborns to group B streptococcal colonization. 

Phospholipids from group B streptococcal (GBS) cell wall cause pulmonary hypertension in experimental animals. When exposed to penicillin, Streptococcus mutans releases phospholipids immediately.  Preliminary data from a NICHD multi-center study have shown that 8.8 percent of newborns colonized by GBS at birth had signs of respiratory distress within 48 hours after birth (cases). In 60 percent of the cases, oxygen supplementation was used, in five percent, mechanical ventilation was required, and in two percent, persistent pulmonary hypertension was diagnosed. Compared with light colonization, heavy colonization increased the rate of respiratory distress 1.73 fold, a discharge diagnosis of respiratory disorder 2.02 fold, a blood/CSF obtained for culture 1.54 fold, and antibiotic administration after birth 1.87 fold.  Penicillin use during labor was associated with a 2.62-fold increase in respiratory distress in the colonized newborn.

These findings support the association of neonatal respiratory distress with “asymptomatic” GBS colonization and with penicillin use during labor.   We hypothesize that newborns colonized with GBS receive bacterial phospholipids leading to pulmonary hypertension and respiratory distress, especially in newborns of penicillin-treated mothers.


The proposed study aims to relate the levels of serum bacterial phospholipids to the occurrence of respiratory distress in newborns of mothers colonized by GBS.  The study will examine the pathologic effects of “asymptomatic” carriage of GBS and the effects of penicillin during labor on the occurrence of respiratory distress in newborns.


It is estimated that approximately 320 newborns of greater than or equal to 32 weeks gestation, with respiratory distress within 24 hours after birth, and approximately 1600 mothers who are GBS carriers will need to be recruited within 12 months.  To achieve that, about 8,000 mothers at  greater than or equal to 32 weeks gestation will be cultured for GBS carriage by obtaining vaginal and rectal swabs on admission to the labor and delivery room. Their newborns will be swabbed from four surface sites (throat, anus, ears, and umbilicus) shortly after birth before the first bath to identify those who are colonized with GBS (and those who are not). 

Maternal and cord blood samples will be collected from two groups of newborns:  1) a random sample of 10 percent of newborns born to colonized mothers (about 160 newborns) and an equal number of randomly selected non-colonized newborns; 2) 10 percent of newborns of penicillin-treated mothers (about 130 samples) and an equal number of randomly selected newborns of untreated mothers.  A 0.25 mL blood sample designated for this study will be collected from newborns with respiratory distress and from asymptomatic newborns (controls) with a case:control ratio of 1:1 at the time of metabolic screening.                                    

Medical records of the symptomatic newborns and the controls, penicillin-treated and -untreated mothers and newborns, and selected newborns of colonized and non-colonized mothers will be reviewed for demographic, clinical, and epidemiological characteristics.

The Request for Proposals, RFP NICHD-2007-03, will be available on or about November 21, 2006 at: http://www.fedbizopps.gov/.  All responsible organizations are encouraged to submit a proposal that will be due February 14, 2007.   No electronic copies of your proposal will be accepted.  This requirement is defined as code 541710 under the North American Industry Classification System (NAICS).  Only electronic copies of the solicitation will be available.  This notice does not commit the Government to the award of a contract.

Contracting Office

Department of Health and Human Services
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases
Office of Acquisitions
NICHD R&D Contracts Management Branch
6100 Executive Boulevard, Room 7A07, MSC 7510
Bethesda, Maryland 20892-7510


Ms. Lynn Salo
Contracting Officer
NICHD R&D Contracts Management Branch
6100 Executive Boulevard, Room 7A07, MSC 7510
Bethesda, Maryland 20892-7510 
Rockville, Maryland 20852 (for express/courier services) 
Email: salol@mail.nih.gov

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