Clinical, Biochemical, Histological and Biophysical Parameters in the Prediction of Cerebral Palsy in Patients With Preterm Labor and Premature Rupture of Membranes

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)5 sites in 4 countries4,673 target enrollmentDecember 8, 1997

Overview

Brief Summary

A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental disabilities, especially mental retardation. Cerebral palsy is frequently associated with neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have resulted in improved survival of very low birthweight infants but also in an increased frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two thirds of preterm neonates are born to mothers with preterm labor with intact membranes or preterm premature rupture of membranes. A growing body of evidence suggests that these conditions are heterogeneous. This is an observational cohort study designed to identify the mechanisms of disease in patients with preterm labor/contractions and preterm premature rupture of membranes and to describe the relationship between clinical, biochemical, histological, biophysical parameters and the development of infant neurological disorders.

Detailed Description

A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental disabilities, especially mental retardation. Cerebral palsy is frequently associated with neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have resulted in improved survival of very low birthweight infants but also in an increased frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two thirds of preterm neonates are born to mothers with preterm labor with intact membranes or preterm premature rupture of membranes. A growing body of evidence suggests that these conditions are heterogeneous. This is an observational cohort study designed to identify the mechanisms of disease in patients with preterm labor/contractions and preterm premature rupture of membranes and to describe the relationship between clinical, biochemical, histological, biophysical parameters and the development of infant neurological disorders.

Registry

clinicaltrials.gov

Start Date

December 8, 1997

End Date

September 15, 2014

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Establish the relationship between these pathologic sub- groups (i.e., intrauterine infection and non infection associated preterm labor/contractions and preterm PROM ) and short and long term neonatal outcome.

Time Frame: 1. gestational age: 20-36

Establish the relationship between these pathologic sub- groups (i.e., intrauterine infection and non infection associated preterm labor /contractions and preterm PROM ) and short and long term neonatal outcome.