The effect of intermittent bolus nasogastric milk feeding versus semi-continuous milk feeding in preterm infants on TOLerance.

Completed

Conditions: feeding tolerancepremature infantsintermittent feedingsemi-continuous feedingvoedingstolerantiepremature kinderenintermitterend voedensemi-continu voeden

Registration Number: NL-OMON24267

Lead Sponsor: J.B. van Goudoever, MD, PhDErasmus MC - Sophia Children's HospitalUniversity Medical CenterDepartment of PediatricsDivision of NeonatologyDr. Molewaterplein 603015 GJ RotterdamThe Netherlands

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

1. Admission to neonatal intensive care unit within 24 hrs after birth;
2. Gestational age under 32 weeks;
3. Birth weight less than 1750 grams.

Exclusion Criteria

1. Simultaneous participation in another trial of which the intervention may influence this trials endpoints;
2. Congenital gastrointestinal obstructions like duodenal atresia, anal atresia, etc.;
3. Any disease entity known to encompass impaired growth other than small gestational age;
4. No informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect on both feeding regimes on feeding tolerance. Primary objective is days to reach full enteral feedings, defined as ¡Ý 120 mL/kg/d.

Secondary Outcome Measures

Name	Time	Method
1. Secondary objective is number of feeding interruptions, days on total parenteral nutrition and number of apnea episodes per day;<br>2. To assess somatic growth in both feeding regimes. To evaluate this variable, the following items will be used: days to regain birth weight, rates of weight gain, knemometry and head circumference;<br>3. To assess complications in both groups measured as catheter related sepsis and necrotizing enterocolitis.