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NCT Number: NCT02389491

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal density formula (Necocate)

Dietary Supplement

In control group,there are 32 infants

high density formula(Infatrini)

Dietary Supplement

In intervention group,there are 32 infants

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study 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

Acronym: CHD

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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