NCT02072109

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 30, 2015

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

February 24, 2014

Last Update Submit

April 29, 2015

Conditions

Premature; Infant, Light-for-datesFeeding Patterns

Keywords

Near infrared spectroscopyBolus nutritionContinuous nutritionMesenteric circulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Bolus feeding

Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit

Continuous feeding

Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit

Eligibility Criteria

Age10 Days - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit - Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Premature BirthFeeding Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavior, AnimalBehavior

Study Officials

  • Gisela Sirota, M.D.

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gisela Sirota, M.D.

CONTACT

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

Ita Litmanovich, M.D.

CONTACT

972-9-7471554litmani@clalit.org.il

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

April 30, 2015

Record last verified: 2014-06

Locations

IL(1)