Condition category
Respiratory
Date applied
29/12/2006
Date assigned
05/01/2007
Last edited
22/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ulrich Herbert Thome

ORCID ID

Contact details

Eythstr 24
Ulm
89075
Germany

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

http://www.uniklinik-ulm.de/

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

Publication citations

Additional files

Editorial Notes