Permissive Hypercapnia in Extremely Low Birthweight Infants

ISRCTN	ISRCTN56143743
DOI	https://doi.org/10.1186/ISRCTN56143743
Secondary identifying numbers	N/A

Submission date: 29/12/2006
Registration date: 05/01/2007
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ulrich Herbert Thome
Scientific

Eythstr 24
Ulm
89075
Germany

Study information

Study design	Randomised controlled multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Permissive Hypercapnia in Extremely Low Birthweight Infants
Study acronym	PHELBI
Study objectives	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(s)	Ethics committee of the University of Ulm, 15/12/2006, ref: 230/06
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	31/12/2007
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	830
Key inclusion criteria	Extremely low birthweight infants (400 g to 1000 g) requiring mechanical ventilation within 24 hours after birth
Key exclusion criteria	Congenital malformations affecting respiratory or cardiac function or requiring surgery
Date of first enrolment	31/12/2007
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Germany

Study participating centre

Eythstr 24

Ulm
89075
Germany

Sponsor information

University Hospital Ulm (Universitätsklinikum Ulm) (Germany)
Hospital/treatment centre

Albert-Einstein-Allee 29
Ulm
89070
Germany

Phone	+49 (0)731 500 0
Email	klinikumsvorstand@uniklinik-ulm.de
Website	http://www.uniklinik-ulm.de/
"ROR"	https://ror.org/05emabm63

Funders

Funder type

Government

Deutsche Forschungsgemeinschaft (Germany) (ref: Th 626/5-1)
Government organisation / National government

Alternative name(s): German Research Association, German Research Foundation, DFG
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2015		Yes	No
Results article	results	13/03/2018		Yes	No

Editorial Notes

18/04/2018: Publication reference added.