NCT02083562

Brief Summary

The purpose of this study is to assess the association of biomarkers on day 7 of life with the development of bronchopulmonary dysplasia in very preterm infants. Additionally a short lung function test at 36 weeks postmenstrual age (PMA) will be performed to investigate whether certain capnographic indices are able to reflect the degree of lung disease. Protocol was amended (under others: additional enrollment of 70 subjects).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

4.6 years

First QC Date

February 25, 2014

Last Update Submit

September 10, 2018

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary dysplasia, preterm infant

Outcome Measures

Primary Outcomes (2)

  • association of plasma biomarker levels (pro-endothelin-1 precursor and other markers of respiratory distress) with the duration of supplemental oxygen dependancy in infancy

    Assessment at 36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months

  • association of capnographic indices with the duration of supplemental oxygen dependancy

    Capnographic indices include expired carbon dioxide volume per breath, slopes of phase II (SII) and slopes of phase III (SIII) of the capnogram.

    36 weeks PMA or until the end of supplemental oxygen dependancy assessed up to 12 months

Secondary Outcomes (8)

  • several definitions of BPD

    36 weeks PMA

  • duration of respiratory support

    participants will be followed for the duration of hospital stay, an expected average of 12 weeks

  • death

    participants will be followed for the duration of hospital stay, an expected average of 12 weeks

  • sepsis

    participants will be followed for the duration of hospital stay, an expected average of 12 weeks

  • necrotizing enterocolitis (NEC)

    participants will be followed for the duration of hospital stay, an expected average of 12 weeks

  • +3 more secondary outcomes

Eligibility Criteria

Age5 Days - 9 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants born below 32 weeks PMA and admitted to the neonatal intensive care units in Basel and Berne, Switzerland.

You may qualify if:

  • parental consent, born below 32 weeks PMA

You may not qualify if:

  • No parental consent, major life-threatening anomalies (cardiac defects, primary pulmonary malformations etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neonatology, University Children's Hospital Basel

Basel, 4031, Switzerland

Location

Department of Neonatology, Inselpital Berne

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Neumann RP, Gerull R, Zannin E, Fouzas S, Schulzke SM. Volumetric Capnography at 36 Weeks Postmenstrual Age and Bronchopulmonary Dysplasia in Very Preterm Infants. J Pediatr. 2022 Feb;241:97-102.e2. doi: 10.1016/j.jpeds.2021.10.019. Epub 2021 Oct 24.

    PMID: 34687691DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Roland P Neumann, MD

    Department of Neonatology, University Children's Hospital Basel, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 11, 2014

Study Start

November 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

CH(2)