Prognosis of Extremely Premature Birth

• Conditions: Infant, Premature, Diseases; Perinatal Morbidity; Development; Problem;Growth

• Registration Number: NCT01150396
• Lead Sponsor: University of Bergen

Brief Summary

Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected. If birth occurs before 28 weeks, detailed information on clinical course of the newborn until discharge from the neonatal intensive care unit will be recorded,and specimens of amniotic fluid, placenta, blood and urine will be collection for inflammatory parameters. After discharge the children will be followed according to a specific protocol until 5 years of age.

Detailed Description

The study includes a regional cohort (Western Norway) of approximately 50 extremely preterm infants born per year over a three year period. Detailed information on fetal condition (growth, circulation, infection), neonatal resuscitation and clinical course (details on ventilatory support, circulation, pulmonary function as assessed with a neonatal spirometry technique, cerebral imaging, nutrition, growth) will be recorded. Biobank samples of blood and amniotic fluid from the mother, and from placenta, blood, urine, and tracheal aspirates will be collected form the infant, primarily to examine for inflammatory parameters. After discharge, follow-up at 6, 12, 36 and 56 months will be conducted using standardized tests (Ages \& Stages, INFANIB, Denver Developmental Screening test, Bayley scales, WPPSI and ABC movement tests).

Study Timeline

• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Study Start: 2010-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-02
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Born with gestational age less than 28 weeks

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health	40 weeks	Outcome in terms of growth, lung function, cerebral imaging (MR), cardiac and intestinal morbidity at discharge from the neonatal intensive care unit

Secondary Outcome Measures

Name	Time	Method
Health	5 years	Growth and motor, cognitive and mental development at 5 years of age (ABC movement test, WPPSI)

Trial Locations

Locations (2)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway