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

Evaluation of Regional Splanchnic Tissue Oxygenation Measured by NIRS (Near Infrared Spectroscopy) in Preterm Infants Receiving Bolus Versus Continuous Feeding

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02072109
Enrollment
20
Registered
2014-02-26
Start date
2014-06-30
Completion date
2016-06-30
Last updated
2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Patterns, Premature; Infant, Light-for-dates

Keywords

Near infrared spectroscopy, Bolus nutrition, Continuous nutrition, Mesenteric circulation

Brief 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.

Detailed description

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 investigators intend to assess 20 clinically stable, appropriate for gestational age preterm infants, born before 32 weeks of gestation and receiving full enteral feedings at least 1 week prior to enrollment with no signs of feeding intolerance. All 20 participants evaluated constitute the 2 study groups: 1. Group 1 = Bolus feeding - before and after one bolus feeding 2. Group 2 = Continuous feeding - before and after one continuous feeding. 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.

Interventions

None listed

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Days to 6 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in splanchnic regional tissue oxygenation before and after a bolus / continuous feeding.10 hoursMeasurement of the regional tissue oxygenation of the intestines using NIRS (Near Infra-Red Spectroscopy) technology before and after a bolus feeding and then a continuous feeding.

Countries

Israel

Contacts

Primary ContactGisela Sirota, M.D.
gisela.sirota@clalit.org.il972-9-7472229
Backup ContactIta Litmanovich, M.D.
litmani@clalit.org.il972-9-7471554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026