Glutamine-Enriched Enteral Feeding in very low birth weight infants
| ISRCTN | ISRCTN73254583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73254583 |
| Secondary identifying numbers | NTR205 |
- Submission date
- 14/07/2004
- Registration date
- 09/08/2004
- Last edited
- 04/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Willem Fetter
Scientific
Scientific
Vrije University Medical Centre
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 2413 |
|---|---|
| w.fetter@vumc.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | GEEF study |
| Study objectives | Very Low Birth Weight (VLBW) infants may be susceptible to glutamine depletion as nutritional supply of glutamine is limited in the first weeks after birth. Glutamine depletion has negative effects on functional integrity of the gut and leads to immunosuppression. This double-blind randomised controlled trial is designed to investigate the effect of glutamine-enriched enteral nutrition on feeding tolerance, infectious morbidity and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of glutamine in postnatal adaptation of the gut and modulation of the immune response. |
| Ethics approval(s) | The National Central Committee on research involving human subjects and the Medical Ethical Review Board of our hospital approved the study protocol. |
| Health condition(s) or problem(s) studied | Very low birth weight infants |
| Intervention | Enteral glutamine supplementation in a dose of 0.3 g/kg/day between days three and 30 of life versus isonitrogenous placebo supplementation (alanine). |
| Intervention type | Supplement |
| Primary outcome measure | Time to full enteral feeding, defined as a feeding volume greater than or equal to 120 mL/kg/day. |
| Secondary outcome measures | 1. Feeding tolerance: 1.1. Age at finishing parenteral nutrition 1.2. Days of no enteral feeding during study period 1.3. Necrotising enterocolitis 2. Infectious morbidity: 2.1. Serious infections 2.2. Number of infectious episodes 2.3. Cultured micro-organisms 3. Short-term outcomes: 3.1. Weight z scores at birth, day 30 and at discharge 3.2. Patent ductus arteriosus 3.3. Ventilatory support 3.4. Use of oxygen at postmenstrual age of 36 weeks 3.5. Intraventricular hemorrhage 3.6. Retinopathy of prematurity 3.7. Death 3.8. Age at discharge from NICU and at discharge home 4. Intestinal permeability, determined during the 30 day study period 5. Faecal flora, determined during the 30 day study period 6. Plasma Th1/Th2 cytokine concentrations, determined during the 30 day study period 7. Plasma amino acid profiles, determined during the 30 day study period |
| Overall study start date | 16/09/2001 |
| Completion date | 19/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 107 |
| Key inclusion criteria | 1. Infants with a gestational age less than 32 weeks and/or a birth weight less than 1500 g 2. Admitted to the level III Neonatal Intensive Care Unit (NICU) of the Vrije University Medical Centre (VUMC) 3. Written informed consent obtained from all parents |
| Key exclusion criteria | 1. Major chromosomal or congenital anomalies 2. Death less than 48 hours after birth 3. Transfer to another hospital less than 48 hours after birth 4. Admission from an extraregional hospital |
| Date of first enrolment | 16/09/2001 |
| Date of final enrolment | 19/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 2413 |
|---|---|
| w.fetter@vumc.nl | |
| Website | http://www.vumc.nl/english/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Industry
Nutricia Nederland B.V. (The Netherlands) - provided neonatal glutamine and placebo supplementation
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 01/09/2004 | Yes | No | |
| Other publications | 01/06/2005 | Yes | No | ||
| Other publications | 01/07/2005 | Yes | No | ||
| Results article | 01/09/2006 | Yes | No | ||
| Other publications | 01/08/2007 | Yes | No | ||
| Other publications | 01/11/2007 | Yes | No |
