Prognosis of Extremely Premature Birth

Infant, Premature, Diseases Clinical Trial

— BabyPEP  

Official title:

Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01150396
• Other study ID #: 2010/496
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2010
• Last updated: June 1, 2015
• Start date: July 2010
• Est. completion date: December 2018

Study information

• Verified date: June 2015
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Weeks to 27 Weeks

Eligibility

Inclusion Criteria:

• Born with gestational age less than 28 weeks

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Development
• Infant, Premature, Diseases
• Perinatal Morbidity
• Premature Birth
• Problem;Growth

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital, Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health	Outcome in terms of growth, lung function, cerebral imaging (MR), cardiac and intestinal morbidity at discharge from the neonatal intensive care unit	40 weeks	No
Secondary	Health	Growth and Developmental outcome at 12 months corrected age	1 year	No
Secondary	Health	Outcome in terms of growth, behavior and psychomotor development (Bayley scales)	3 years	No
Secondary	Health	Growth and motor, cognitive and mental development at 5 years of age (ABC movement test, WPPSI)	5 years	No