CompletedNot Applicable

Early Exclusive Enteral Nutrition in Early Preterm Infants

Canada69 participantsStarted 2019-04-16

Plain-language summary

Enteral nutrition in preterm infants is usually started and advanced slowly until reaching full enteral feeds. Most preterm infants born before 34 weeks gestation require parenteral fluids to maintain normal blood sugar level and prevent excessive weight loss and dehydration. Availability of donor human milk (DHM) along with low incidence of necrotizing enterocolitis (NEC) in preterm infants born at 30-33 weeks have encouraged neonatologists to start feeding early and advance it faster in order to shorten time on parenteral nutrition (PN) and minimize the need for intravenous access. The objectives of this trial is to study whether exclusive enteral nutrition from day of birth (i.e. no PN) results in shorter time to achieve full enteral feed when compared with traditional feeding regimen that involves a combination of PN and progressive enteral feeding.

Who can participate

Age range

48 Hours

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

. Preterm infants born at 30 0/7 - 33 6/7 weeks gestation
. Birth weight greater than 1000 g
. Consent to use donor human milk
. Postnatal age is less than 48 hours from birth
. Infant is ready to start on feeding (as per clinical team) or feeding volume, when already started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feeds based on current feeding policy or physician descrition (total volume of the received feeds is ≤20 ml/kg per day).

Exclusion criteria

. Cord PH \< 7.00 or Cord base access (BE) \< -16

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

Duration to achieve of full enteral feeds in days

Timeframe: Till 30 days of life

Trial details

NCT IDNCT03708068

SponsorBelal Alshaikh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-24

View on ClinicalTrials.gov More Enteral Nutrition trials