search
Back to results

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

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
normal density formula (Necocate)
high density formula(Infatrini)
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease focused on measuring high density formula, heart defects, infant

Eligibility Criteria

1 Day - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    normal density formula (Neocate)

    high density formula (Infatrini)

    Arm Description

    In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days

    In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days

    Outcomes

    Primary Outcome Measures

    weight gain at the 7th day (g)
    the 7th day body weight minus baseline body weight
    the number of participants with feeding intolerance
    Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped.

    Secondary Outcome Measures

    Duration of mechanical ventilation
    evaluate the long term effect of feeding high density formula
    length of Cardiac Intensive Care Unit(CCU) stay
    evaluate the long term effect of feeding high density formula
    the number of participants with poor wound healing
    evaluate the long term effect of feeding high density formula
    the number of participants with necrotizing enterocolitis
    evaluate the long term effect of feeding high density formula

    Full Information

    First Posted
    February 5, 2015
    Last Updated
    November 9, 2015
    Sponsor
    Children's Hospital of Fudan University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02389491
    Brief Title
    Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants
    Acronym
    CHD
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital of Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Disease
    Keywords
    high density formula, heart defects, infant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    normal density formula (Neocate)
    Arm Type
    Active Comparator
    Arm Description
    In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days
    Arm Title
    high density formula (Infatrini)
    Arm Type
    Experimental
    Arm Description
    In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    normal density formula (Necocate)
    Intervention Description
    In control group,there are 32 infants
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    high density formula(Infatrini)
    Intervention Description
    In intervention group,there are 32 infants
    Primary Outcome Measure Information:
    Title
    weight gain at the 7th day (g)
    Description
    the 7th day body weight minus baseline body weight
    Time Frame
    from the first day starting enteric feeding to the 7th days
    Title
    the number of participants with feeding intolerance
    Description
    Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped.
    Time Frame
    from the first day starting enteric feeding to the 7th day
    Secondary Outcome Measure Information:
    Title
    Duration of mechanical ventilation
    Description
    evaluate the long term effect of feeding high density formula
    Time Frame
    participants will be followed for the duration of hospital stay, an expected average of 4 weeks
    Title
    length of Cardiac Intensive Care Unit(CCU) stay
    Description
    evaluate the long term effect of feeding high density formula
    Time Frame
    participants will be followed for the duration of hospital stay, an expected average of 4 weeks
    Title
    the number of participants with poor wound healing
    Description
    evaluate the long term effect of feeding high density formula
    Time Frame
    participants will be followed for the duration of hospital stay, an expected average of 4 weeks
    Title
    the number of participants with necrotizing enterocolitis
    Description
    evaluate the long term effect of feeding high density formula
    Time Frame
    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination aged from 1 day to 12 months accept extracorporeal circulation open-heart surgery family members voluntarily participate in this study Exclusion Criteria: patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction accept total parenteral nutrition predicted the length of CCU stay is less than five days patients have abdominal distention, diarrhea, vomiting
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gu Ying, docter
    Organizational Affiliation
    Children Hospital of Fudan University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs