Glutamine-Enriched Enteral Feeding in very low birth weight infants

ISRCTN	ISRCTN73254583
DOI	https://doi.org/10.1186/ISRCTN73254583
Protocol serial number	NTR205
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	Nutricia Nederland B.V. (The Netherlands) - provided neonatal glutamine and placebo supplementation

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

Vrije University Medical Centre
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 444 2413
Email	w.fetter@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, placebo controlled, parallel group, double blinded trial
Secondary study design	Randomised controlled trial
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(s)	Time to full enteral feeding, defined as a feeding volume greater than or equal to 120 mL/kg/day.
Key secondary outcome measure(s)	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
Completion date	19/10/2004

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

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	Peer reviewed?	Patient-facing?
Results article		01/09/2006	Yes	No
Protocol article	Protocol	01/09/2004	Yes	No
Other publications		01/06/2005	Yes	No
Other publications		01/07/2005	Yes	No
Other publications		01/08/2007	Yes	No
Other publications		01/11/2007	Yes	No