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Prognosis of Extremely Premature Birth (BabyPEP)

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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

Study Description
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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.

Condition or disease
Infant, Premature, Diseases Perinatal Morbidity Development Problem;Growth

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
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks
Study Start Date : July 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Health [ Time Frame: 1 year ]
    Growth and Developmental outcome at 12 months corrected age

  2. Health [ Time Frame: 3 years ]
    Outcome in terms of growth, behavior and psychomotor development (Bayley scales)

  3. Health [ Time Frame: 5 years ]
    Growth and motor, cognitive and mental development at 5 years of age (ABC movement test, WPPSI)


Biospecimen Retention:   Samples Without DNA
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)

Eligibility Criteria
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Ages Eligible for Study:   22 Weeks to 27 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants born before 28 weeks' gestational age
Criteria

Inclusion Criteria:

  • Born with gestational age less than 28 weeks

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150396


Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, N-5021
Contact: Trond Markestad, MD, PhD    +47 55975200 ext 5245    trond.markestad@helse-bergen.no   
Contact: Thomas Halvorsen, MD, PhD    +47 55975200 ext 5152    thomas.halvorsen@helse-bergen.no   
Stavanger University Hospital Recruiting
Stavanger, Norway, N-4011
Contact: Knut Øymar, MD, PhD    +47 51513762    oykn@sus.nno   
Contact: Torbjørn Moe Eggebø, MD    +47 51518000    tme@sus.no   
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Helse Stavanger HF
Investigators
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Principal Investigator: Trond Markestad, MD, PhD University of Bergen, Faculty of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Trond Markestad, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT01150396    
Other Study ID Numbers: 2010/496
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015
Keywords provided by Trond Markestad, University of Bergen:
extremely premature infant
outcome
follow-up
Additional relevant MeSH terms:
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Premature Birth
Infant, Premature, Diseases
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases