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
Not provided at time of registration
Contact information
Dr Ulrich Herbert Thome
Scientific
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 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(s) | Ethics committee of the University of Ulm, 15/12/2006, ref: 230/06 |
| 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 |
| 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 |
| Overall study end date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 830 |
| Participant inclusion criteria | Extremely low birthweight infants (400 g to 1000 g) requiring mechanical ventilation within 24 hours after birth |
| 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
Study participating centre
Eythstr 24
Ulm
89075
Germany
89075
Germany
Sponsor information
University Hospital Ulm (Universitätsklinikum Ulm) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Albert-Einstein-Allee 29
Ulm
89070
Germany
| Phone | +49 (0)731 500 0 |
|---|---|
| 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
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.
