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

Fudan University

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Dietary Supplement: normal density formula (Necocate); Dietary Supplement: high density formula(Infatrini)

Study type: Interventional

Funder types: Other

Identifiers

NCT02389491

FNF201426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

64 participants in 2 patient groups

normal density formula (Neocate)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: normal density formula (Necocate)

high density formula (Infatrini)

Experimental group

Description:

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

Treatment:

Dietary Supplement: high density formula(Infatrini)