Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Permissive Hypercapnia in Extremely Low Birthweight Infants
Acronym
PHELBI
Study hypothesis
A higher than traditional arterial carbon dioxide pressure (PaCO2) target range (permissive hypercapnia) in mechanically ventilated extremely low birth weight infants reduces the combined incidence of bronchopulmonary dysplasia or death.
Ethics approval
Ethics committee of the University of Ulm, 15/12/2006, ref: 230/06
Study design
Randomised controlled multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Infant respiratory distress syndrome
Intervention
Different PaCO2 target range:
Experimental intervention: PaCO2 target range 55 to 65 mmHg (day one to three of life) , 60 to 70 mmHg (day four to six), 65 to 75 mmHg (day seven to 14).
Control intervention: PaCO2 target range 40 to 50 mmHg on day one to three, 45 to 55 mmHg on days four to six, 50 to 60 mmHg on day seven to 14.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
1. Bronchopulmonary dysplasia at 36 weeks postmenstrual age
2. Death by intention to treat
Secondary outcome measures
1. Incidence of intracranial haemorrhages
2. Incidence of air leaks
3. Duration of mechanical ventilation
4. Positive pressure support and supplemental oxygen
5. Inflammatory mediators in tracheal aspirates
6. Neurodevelopmental outcome at 18 to 24 months corrected age, per protocol ananlysis of primary outcome
Overall trial start date
31/12/2007
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Extremely low birthweight infants (400 g to 1000 g) requiring mechanical ventilation within 24 hours after birth
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
830
Participant exclusion criteria
Congenital malformations affecting respiratory or cardiac function or requiring surgery.
Recruitment start date
31/12/2007
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Eythstr 24
Ulm
89075
Germany
Sponsor information
Organisation
University Hospital Ulm (Universitätsklinikum Ulm) (Germany)
Sponsor details
Albert-Einstein-Allee 29
Ulm
89070
Germany
+49 (0)731 500 0
klinikumsvorstand@uniklinik-ulm.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Deutsche Forschungsgemeinschaft (Germany) (ref: Th 626/5-1)
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26088180