UnknownNot Applicable

Comparison of Regional Splanchnic Tissue Oxygenation Measured by NIRS in Preterm Babies Fed Bolus Versus Continuous Feeding

Israel20 participantsStarted 2014-06

Plain-language summary

Early initiation of enteral feeding, achievement of full enteral feeding and cessation of parenteral nutrition are extremely important in the very premature infant. This way it is possible to achieve good post-natal growth and developement while minimizing the metabolic and infectious complications of parenteral feeding. There isn't much information in literature regarding the impact of enteral feeding on intestinal blood flow and intestinal regional oxygenation in the preterm infant. There is also no consensus regarding the best regimen of delivering the enteral nutrition - bolus feeding or continuous feeding. The aim of our study is to compare the intestinal regional oxygenation before and after two feeding regimens - bolus feeding and continuous feeding - in clinically stable preterm infants born before 32 weeks gestation. The evaluations will be performed using NIRS technology (Near Infrared Spectroscopy). The study may help to assess which feeding regimen is gentler to the immature intestines (i.e. alters less the splanchnic blood flow and oxygenation) and therefore the preferred way to feed preterm infants.

Who can participate

Age range

10 Days – 6 Months

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: * Born 23+0 to 31+6 weeks gestational age. * Appropriate for gestational age. * Clinically stable. * Full enteral feeding at least 1 week prior to enrollment. * Bolus feeding. * No signs of feeding intolerance. Exclusion Criteria: * Major congenital anomalies (severe heart or cerebral disease, chromosomal abnormalities, any malformation or disease of the gastrointestinal tract). * Previous diagnosis of necrotizing enterocolitis or spontaneous intestinal perforation. * Need for blood transfusion 1 week prior to enrollment. * Need for vasopressor therapy 1 week prior to enrollment. * Cutaneous disease not allowing the placement of the NIRS probe.

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

Change in splanchnic regional tissue oxygenation before and after a bolus / continuous feeding.

Timeframe: 10 hours

Trial details

NCT IDNCT02072109

SponsorMeir Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-02

Contact for this trial

Gisela Sirota, M.D.

972-9-7472229 gisela.sirota@clalit.org.il

View on ClinicalTrials.gov More Premature; Infant, Light-for-dates trials