High Energy Formula Feeding in Infants With Congenital Heart Disease

NCT ID: NCT01850784

Last Updated: 2013-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-10-31

Brief Summary

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High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Detailed Description

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Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Conditions

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Growth Failure Neurodevelopmental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High energy formula

High energy formula (Similac)

Group Type ACTIVE_COMPARATOR

High energy formula

Intervention Type DIETARY_SUPPLEMENT

The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)

Standard formula

Standard formula

Group Type ACTIVE_COMPARATOR

Standard formula

Intervention Type DIETARY_SUPPLEMENT

The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)

Interventions

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High energy formula

The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)

Intervention Type DIETARY_SUPPLEMENT

Standard formula

The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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High energy formula (Similac)

Eligibility Criteria

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Inclusion Criteria

* infants \>35 weeks of gestational age
* infants with CHD
* İnfants fed with formula feeding

Exclusion Criteria

* Major congenital abnormalities except CHD
* infants could not be fed enterally
Minimum Eligible Age

8 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dilek Dilli

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Dilli

Role: STUDY_DIRECTOR

Sami Ulus CH

Locations

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Sami Ulus CH

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Dilek Dilli, Assoc Prof

Role: CONTACT

00903126243

Facility Contacts

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Nazan N Doğan, MD

Role: primary

Other Identifiers

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132/2013

Identifier Type: -

Identifier Source: org_study_id

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