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

Feeding Patterns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02072109
• Other study ID #: 267-13
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: April 29, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2014
• Source: Meir Medical Center
• Contact: Gisela Sirota, M.D.
• Phone: 972-9-7472229
• Email: gisela.sirota[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	Neonatal Intensive Care Unit - Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in splanchnic regional tissue oxygenation before and after a bolus / continuous feeding.	Measurement 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.	10 hours	No