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Early Versus Delayed Feeding in Preterm Growth-Restricted Infants

NCT03443297 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-02-23

No results posted yet for this study

Summary

The introduction of enteral feeds for preterm, growth restricted infants are often delayed due to concern that early introduction may not be tolerated and may increase the risk of necrotizing enterocolitis. However, prolonged enteral fasting may diminish the functional adaptation of the immature gastrointestinal tract and extend the need for parenteral nutrition with its attendant infectious and metabolic risks. Early introduction of small volumes of milk in the form of Trophic feeding, promote intestinal maturation, may enhance feeding tolerance and decrease the time taken to reach full enteral feeding independently of parenteral nutrition.

A Randomized Trial will be carried out over a period of 12 months in Department of Neonatology of BSMMU. Sample size will be 50(25 in each group). Infants with gestation below 35 weeks, birth weight below the 10th percentile for gestational age, will be randomly allocated by web-based randomization to commence enteral feeds "early," whose feeding will be started from 24 to 48 hours of age or "late," whose feeding will be started from 48 to 72 hours of age. Gradually feeding will be increased. Rate of advancement of feeding will be same for both groups. Primary outcomes will be time to achieve full enteral feeding sustained for 72 hours. Statistical analyses will be performed by using Fisher Exact test and by Student's t test for categorical data and quantitative data respectively. Logistic regression analyses will be performed to determine the role of independent variable.

Conditions

  • Preterm Infant
  • IUGR

Interventions

OTHER

breast milk

Feeding with breast milk will be started in early feeding group from 24 to 48 hours of age or in late feeding group, from 48 to 72 hours of age. Initially 4 hourly feeding will be started with 0.5ml and 1 ml expressed breast milk in babies with birth weight \<1200 grams and \>1200 grams respectively. gradually volume of milk should be increased

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-12-31
Completion
2018-12-31

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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 NCT03443297 on ClinicalTrials.gov