Infant, Premature, DiseasesBabyPEPNCT01150396
Prognosis of Extremely Premature Birth
An observational study of Infant, Premature, Diseases and Perinatal Morbidity, run by University of Bergen at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 27 weeks
- Conditions the study is for
- Infant, Premature, Diseases, Perinatal Morbidity, Development
- How many people
- 160 participants
- Where
- 2 sitesNorway
- Study dates
- Jul 2010to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 27 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants born before 28 weeks' gestational age
Who may be able to join
- Born with gestational age less than 28 weeks
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Haukeland University Hospital
Bergen, N-5021
Trond Markestad, MD, PhD, +47 55975200 ext. 5245, trond.markestad@helse-bergen.no
Thomas Halvorsen, MD, PhD, +47 55975200 ext. 5152, thomas.halvorsen@helse-bergen.no
- Recruiting
Stavanger University Hospital
Stavanger, N-4011
Knut Øymar, MD, PhD, +47 51513762, oykn@sus.nno
Torbjørn Moe Eggebø, MD, +47 51518000, tme@sus.no
About this study
Official title: Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks
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.
Read the 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).
- Keywords
- extremely premature infant, outcome, follow-up
- Medical subject headings
- Infant, Premature, Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Health
Outcome in terms of growth, lung function, cerebral imaging (MR), cardiac and intestinal morbidity at discharge from the neonatal intensive care unit
Measured: 40 weeks
Secondary outcomes (3)
Health
Growth and Developmental outcome at 12 months corrected age
Measured: 1 year
Health
Outcome in terms of growth, behavior and psychomotor development (Bayley scales)
Measured: 3 years
Health
Growth and motor, cognitive and mental development at 5 years of age (ABC movement test, WPPSI)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Helse Stavanger HF
- Responsible party
- Principal investigator, Trond Markestad, University of Bergen
- Investigators
- Trond Markestad, MD, PhD, Principal investigator, University of Bergen, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150396
- Sponsor's protocol ID
- 2010/496
- Acronym
- BabyPEP
- Status last verified
- Jun 2015
- First submitted
- 23 Jun 2010
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29074512
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks
- ClinicalTrials.gov ID
- NCT01150396
- Acronym / sponsor ID
- BabyPEP / 2010/496
- Keywords
- extremely premature infant, outcome, follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Helse Stavanger HF
- Study start
- Jul 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 27 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born before 28 weeks' gestational age
Key inclusion criteria (1 listed)
- Born with gestational age less than 28 weeks
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Health
Time frame: 1 year
Health
Time frame: 3 years
Health
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Derived from this study: PubMed 29074512Bentsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trond Markestad, MD, PhD principal investigator
University of Bergen, Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases and Perinatal Morbidity, run by University of Bergen at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.