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Clinical Trials/NCT01150396
NCT01150396UnknownNot Applicable

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

University of Bergen2 sites in 1 country160 target enrollmentStarted: July 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
160
Locations
2
Primary Endpoint
Health

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
22 Weeks to 27 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Born with gestational age less than 28 weeks

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Health

Time Frame: 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 Outcomes

  • Health(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Trond Markestad

Professor

University of Bergen

Study Sites (2)

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