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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Primary Endpoint
- weight gain at the 7th day (g)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: normal density formula (Necocate) (Dietary Supplement)
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
Intervention: high density formula(Infatrini) (Dietary Supplement)
Outcomes
Primary Outcomes
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
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
- the number of participants with poor wound healing(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Duration of mechanical ventilation(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- length of Cardiac Intensive Care Unit(CCU) stay(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- the number of participants with necrotizing enterocolitis(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)