Cysteine requirements for preterm infants
| ISRCTN | ISRCTN35832828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35832828 |
| Secondary identifying numbers | NTR245 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 04/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms M A Riedijk
Scientific
Scientific
Erasmus Medical Centre
Sophia Children's Hospital
Department of Neonatology, Room SP3433
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
| Phone | +31 (0)10 463 6363 |
|---|---|
| m.riedijk@erasmus.nl |
Study information
| Study design | Multicentre, randomised, single blind, active controlled, crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | To determine the requirement of cysteine in preterm infants with different gestational ages and post-natal age |
| Study objectives | 1. Cysteine is an essential amino acid for newborn preterm infants 2. Cysteine requirements change rapidly with postnatal age 3. The change in cysteine requirement with age is based upon cystathionase activity 4. Intestinal cystathionase activity is of major importance for the conversion of methionine to cysteine |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Premature infants, glutathione (GSH) deficiency |
| Intervention | Infants receive a test diet with graded amounts of cystine for 32 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cystine |
| Primary outcome measure | 1. Fractional oxidation of 13C-phenylalanine 2. Whole body flux of 13C-phenylalanine |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/11/2004 |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Infants born with a gestational age of 26 - 29 weeks will be studied at a post-conceptional age of 30 - 32 weeks and at a post-conceptional age of 35 - 37 weeks 2. Infants born at a gestational age of 32 - 34 weeks will also be studied at a post-conceptional age of 35 - 37 weeks |
| Key exclusion criteria | 1. Congenital metabolic disease 2. Congenital anomalies 3. Gastrointestinal diseases |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 CB
Netherlands
3000 CB
Netherlands
Sponsor information
Sophia Foundation For Scientific Research (SSWO) (Netherlands)
Research organisation
Research organisation
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
| Phone | +31 (0)10 463 6079 |
|---|---|
| info@vriendensophia.nl | |
| Website | http://www.vriendensophia.nl/?/sophia_home/welkom |
Funders
Funder type
Hospital/treatment centre
Sophia Children's Hospital Fund (The Netherlands)
No information available
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 |
