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Prognosis of Extremely Premature Birth (BabyPEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01150396
Recruitment Status : Unknown
Verified June 2015 by Trond Markestad, University of Bergen.
Recruitment status was:  Recruiting
First Posted : June 25, 2010
Last Update Posted : June 2, 2015
Sponsor:
Collaborators:
Haukeland University Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Trond Markestad, University of Bergen

Tracking Information
First Submitted Date June 23, 2010
First Posted Date June 25, 2010
Last Update Posted Date June 2, 2015
Study Start Date July 2010
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2010)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2010)
  • Health [ Time Frame: 1 year ]
    Growth and Developmental outcome at 12 months corrected age
  • Health [ Time Frame: 3 years ]
    Outcome in terms of growth, behavior and psychomotor development (Bayley scales)
  • Health [ Time Frame: 5 years ]
    Growth and motor, cognitive and mental development at 5 years of age (ABC movement test, WPPSI)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognosis of Extremely Premature Birth
Official Title Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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)
Sampling Method Non-Probability Sample
Study Population Infants born before 28 weeks' gestational age
Condition
  • Infant, Premature, Diseases
  • Perinatal Morbidity
  • Development
  • Problem;Growth
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 24, 2010)		 160
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Born with gestational age less than 28 weeks

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Weeks to 27 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01150396
Other Study ID Numbers 2010/496
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Trond Markestad, University of Bergen
Original Responsible Party Trond Markestad/Professor, University of Bergen, faculty of Medicine, Department of Clinical Medicine
Current Study Sponsor University of Bergen
Original Study Sponsor Same as current
Collaborators
  • Haukeland University Hospital
  • Helse Stavanger HF
Investigators
Principal Investigator: Trond Markestad, MD, PhD University of Bergen, Faculty of Medicine
PRS Account University of Bergen
Verification Date June 2015