Clinical trial NCT02072109: Comparison of Regional Splanchnic Tissue Oxygenation Measured by NIRS in Preterm Babies Fed Bolus Versus Continuous Feeding
Official title: Evaluation of Regional Splanchnic Tissue Oxygenation Measured by NIRS (Near Infrared Spectroscopy) in Preterm Infants Receiving Bolus Versus Continuous Feeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature; Infant, Light-for-dates
Feeding Patterns
Keywords: Near infrared spectroscopy
Bolus nutrition
Continuous nutrition
Mesenteric circulation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in splanchnic regional tissue oxygenation before and after a bolus / continuous feeding.
timeFrame: 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Neonatal Intensive Care Unit - Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Gisela Sirota, M.D.
role: PRINCIPAL_INVESTIGATOR
References: