ClinicalTrials.Veeva

Menu

Prognosis of Extremely Premature Birth (BabyPEP)

U

University of Bergen

Status

Unknown

Conditions

Perinatal Morbidity
Infant, Premature, Diseases
Development
Problem;Growth

Study type

Observational

Funder types

Other

Identifiers

NCT01150396
2010/496

Details and patient eligibility

About

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.

Full 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).

Enrollment

160 estimated patients

Sex

All

Ages

22 to 27 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Born with gestational age less than 28 weeks

Exclusion criteria

  • None

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems