Glutathione Metabolism in Neonates
| ISRCTN | ISRCTN82896385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82896385 |
| Protocol serial number | NTR243 |
| Sponsor | Sophia Foundation For Scientific Research (SSWO) (Netherlands) |
| Funder | Friends of the Sophia Foundation (Stichting Vrienden van het Sophia) (Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F W J te Braake
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Room Sk-2210
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
| Phone | +31 (0)10 463 6015 |
|---|---|
| f.tebraake@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Glutathione kinetics and oxidative stress in preterm infants |
| Study objectives | 1. Low glutathione (GSH) status in preterm and sick term infants is due to a high utilisation rate of GSH rather than a low synthetic capacity 2. Current feeding strategies in preterm and sick term infants fail to supply enough substrate for an adequate GSH production rate |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Glutathione (GSH) deficiency |
| Intervention | Preterm infants are resuscitated with different oxygen concentrations at birth |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glutathione |
| Primary outcome measure(s) | Glutathione synthesis rate, measured at day 2 post-natal |
| Key secondary outcome measure(s) | 1. Concentration of oxidative stress markers, Apgar Score, oxygen saturation and heart rate in first 20 minutes after birth, measured on day 1 and day 7 2. Mortality 3. The incidence of bronchopulmonary dysplasia |
| Completion date | 11/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 20 |
| Key inclusion criteria | Preterm infants with birth weights less than 1500 g and term infants. Infants in both groups should have arterial catheters for the purpose of obtaining blood samples. |
| Key exclusion criteria | 1. Known congenital abnormalities 2. Chromosome defects 3. Metabolic disease 4. Endocrine, renal, or hepatic disorder |
| Date of first enrolment | 11/08/2005 |
| Date of final enrolment | 11/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/11/2009 | 18/02/2021 | Yes | No |
Editorial Notes
18/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
