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

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ClinicalTrials.gov Identifier: NCT02389491
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Dietary Supplement: normal density formula (Necocate) Dietary Supplement: high density formula(Infatrini) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389491


Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Chair: Gu Ying, docter Children Hospital of Fudan University

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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02389491     History of Changes
Other Study ID Numbers: FNF201426
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Children's Hospital of Fudan University:
high density formula
heart defects
infant

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities