Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants (CHD)

November 9, 2015 updated by: Children's Hospital of Fudan University

Effect of a High Density Formula on Growth and Safety in Early Postoperative Infants With Congenital Heart Disease Duration of Cardiac Intensive Care Unit（CCU）Stay: a Randomized Clinical Trial

The purpose of this study is to explore the effects of high density formula in early postoperative infants with congenital heart disease and to assess its safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The number of infants born with CHD increases every year and most CHD infants are suffered with malnutrition.Recent studies have shown that increasing energy intake in CHD infants can improve their nutrition status.But there are no high qualified evidences supporting that high density formula can promote infants' nutrition status and ensure its safety. The hypothesis of the current study is that high density formula intake can increase infants'weight and it's safe.

The current study adopts randomized,controlled intervention trial, gives high density formula(Infatrini,100kcal/100ml)to CHD infants in intervention group and normal density formula（Neocate,67kcal/100ml）in control group. Intervention begins when infants start enteral nutrition after operation and continues for 7days.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination
  2. aged from 1 day to 12 months
  3. accept extracorporeal circulation open-heart surgery
  4. family members voluntarily participate in this study

Exclusion Criteria:

  1. patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction
  2. accept total parenteral nutrition
  3. predicted the length of CCU stay is less than five days
  4. patients have abdominal distention, diarrhea, vomiting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: normal density formula (Neocate)
In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days
Dietary supplement: normal density formula (Necocate)
In control group,there are 32 infants
Experimental: high density formula (Infatrini)
In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days
Dietary supplement: high density formula(Infatrini)
In intervention group,there are 32 infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight gain at the 7th day (g)
Time Frame: from the first day starting enteric feeding to the 7th days
the 7th day body weight minus baseline body weight
from the first day starting enteric feeding to the 7th days
the number of participants with feeding intolerance
Time Frame: from the first day starting enteric feeding to the 7th day
Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped.
from the first day starting enteric feeding to the 7th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
evaluate the long term effect of feeding high density formula
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
length of Cardiac Intensive Care Unit(CCU) stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
evaluate the long term effect of feeding high density formula
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
the number of participants with poor wound healing
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
evaluate the long term effect of feeding high density formula
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
the number of participants with necrotizing enterocolitis
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
evaluate the long term effect of feeding high density formula
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Chair: Gu Ying, docter, Children Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNF201426

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Disease

Clinical Trials on normal density formula (Necocate)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe