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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02072109
Other study ID # 267-13
Secondary ID
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


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
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