Prognosis of Extremely Premature Birth

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01150396

Acronym

BabyPEP

Enrollment

160

Registered

2010-06-25

Start date

2010-07-31

Completion date

2018-12-31

Last updated

2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

extremely premature infant, outcome, follow-up

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Weeks to 27 Weeks

Healthy volunteers

Inclusion criteria

* Born with gestational age less than 28 weeks

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Health	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

Measure	Time frame	Description
Health	1 year	Growth and Developmental outcome at 12 months corrected age

Countries

Norway

Outcome results