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Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants

NCT02187978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-09-29

No results posted yet for this study

Summary

The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants. In current clinical practice, the introduction of oral feeds for VLBW infants is often preceded by a period of fasting or minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be associated with potential disadvantages and increased infectious and metabolic complications related to prolonged fasting and use of parenteral nutrition. The studies conducted till date have shown better outcomes and improved postnatal growth with early initiation and fast advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total oral feeds on day 1 of life. No such study has been conducted on early total oral feeding but observational work in our unit has shown it to be safe without any increased incidence of feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW infants all over the world, the investigators decided to assess the effect of early total enteral feeding in stable VLBW infants.

Conditions

  • Nutrition of Preterm Infants

Interventions

OTHER

Early total enteral feeding (ETEF)

In ETEF Group total required volume of fluid will be administered as oral feeds and no intravenous fluid will be given. Feeds will be started at 80 mL/kg and increased till 150ml/kg is attained.

OTHER

Conventional enteral feeding (CEF)

CEF Group will receive some feed and some Intravenous fluids. Feeds will be slowly increased from 20 mL/kg on day 1 till full feeds 150ml/kg is attained on day 6 of life.

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • Sushma Nangia, MD,DM · Lady Hardinge Medical College & Kalawati Saran Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
120 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-06-30
Completion
2015-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02187978 on ClinicalTrials.gov