Glutamine-Enriched Enteral Feeding in very low birth weight infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN73254583

Enrollment

107

Registered

2004-08-09

Start date

2001-09-16

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very low birth weight infants Pregnancy and Childbirth Very low birth weight infants

Interventions

Enteral glutamine supplementation in a dose of 0.3 g/kg/day between days three and 30 of life versus isonitrogenous placebo supplementation (alanine).

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Time to full enteral feeding, defined as a feeding volume greater than or equal to 120 mL/kg/day.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026