Clinical trial NCT02389491: Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants
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
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: high density formula
heart defects
infant
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: weight gain at the 7th day (g)
timeFrame: from the first day starting enteric feeding to the 7th days
measure: the number of participants with feeding intolerance
timeFrame: from the first day starting enteric feeding to the 7th day
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: length of Cardiac Intensive Care Unit(CCU) stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: the number of participants with poor wound healing
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: the number of participants with necrotizing enterocolitis
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Children Hospital of Fudan University
name: Gu Ying, docter
role: STUDY_CHAIR
References: