Prognosis of Extremely Premature Birth

NCT ID: NCT01150396

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2018-12-31

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Born with gestational age less than 28 weeks

Exclusion Criteria

• None

• Minimum Eligible Age: 22 Weeks
• Maximum Eligible Age: 27 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Trond Markestad

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trond Markestad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen, Faculty of Medicine

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Stavanger University Hospital

Stavanger, , Norway

Site Status: RECRUITING

Countries

Norway

Facility Contacts

Trond Markestad, MD, PhD

Role: primary

trond.markestad@helse-bergen.no

+47 55975200 ext. 5245

Thomas Halvorsen, MD, PhD

Role: backup

thomas.halvorsen@helse-bergen.no

+47 55975200 ext. 5152

Knut Øymar, MD, PhD

Role: primary

oykn@sus.nno

+47 51513762

Torbjørn Moe Eggebø, MD

Role: backup

tme@sus.no

+47 51518000

References

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.

Reference Type: DERIVED

PMID: 29074512 (View on PubMed)

Other Identifiers

2010/496

Identifier Type: -

Identifier Source: org_study_id