Prognosis of Extremely Premature Birth
BabyPEP
Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks
1 other identifier
observational
160
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 2, 2015
June 1, 2015
7.4 years
June 23, 2010
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Health
1 year
Health
3 years
Health
5 years
Eligibility Criteria
Infants born before 28 weeks' gestational age
You may qualify if:
- Born with gestational age less than 28 weeks
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bergenlead
- Haukeland University Hospitalcollaborator
- Helse Stavanger HFcollaborator
Study Sites (2)
Haukeland University Hospital
Bergen, N-5021, Norway
Stavanger University Hospital
Stavanger, N-4011, Norway
Related Publications (1)
Bentsen MH, Markestad T, Oymar K, Halvorsen T. Lung function at term in extremely preterm-born infants: a regional prospective cohort study. BMJ Open. 2017 Oct 25;7(10):e016868. doi: 10.1136/bmjopen-2017-016868.
PMID: 29074512DERIVED
Biospecimen
Blood and amniotic fluid from mother Placenta Blood from umbilical cord and repeated blood samples from the infant Repeated urine samples from infant repeated tracheal spirates from the infant (while intubated)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trond Markestad, MD, PhD
University of Bergen, Faculty of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 23, 2010
First Posted
June 25, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
June 2, 2015
Record last verified: 2015-06