UnknownNot Applicable

Early Versus Delayed Feeding in Preterm Growth-Restricted Infants

50 participantsStarted 2018-03-01

Plain-language 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.

Who can participate

Age range

1 Minute – 4 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All growth restricted preterm Infants of both sexes with gestational age 35 weeks or less and birth weight below 10th percentile for gestational age Exclusion Criteria: * • Hemodynamically unstable critically ill neonates. * Newborn with severe perinatal asphyxia. * Newborn with polycythemia requiring exchange transfusion * Newborn with major congenital anomalies * Syndromic manifestations or chromosomal malformations * Suspected inborn errors of metabolism. * Any baby who will have proven sepsis with shock or necrotizing enterocolitis will be excluded and will be replaced by new one in same category as per protocol analysis. * Any baby who develop shock (due to sepsis, cardiogenic, hypovolemic etc.) will be excluded and will be replaced by new one in same category as per protocol analysis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Association of feeding with weight gain pattern

Timeframe: 1 year

Trial details

NCT IDNCT03443297

SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-31

View on ClinicalTrials.gov More Preterm Infant trials