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

Completed

• Conditions: Preterm Birth; Pregnancy

• Registration Number: NCT00342667
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Timeline

• Study Start: 1997-12-08
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-21
• Primary Completion: 2014-09-15
• Study Completion: 2014-09-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4673

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (5)

Sotero del Rio Hospital; 🇨🇱 Puente Alto, Chile

National Institute of Child Health and Human Development (NICHD), 9000 Rockville; 🇺🇸 Bethesda, Maryland, United States

Hutzel Women's Hospital; 🇺🇸 Detroit, Michigan, United States

Ben Gurion University /Soroka Medical Center; 🇮🇱 Beer-Sheva, Israel

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of