NCT02389491

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	normal density formula (Necocate)	In control group,there are 32 infants
DIETARY_SUPPLEMENT	high density formula(Infatrini)	In intervention group,there are 32 infants

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-03-17
• Last updated: 2015-11-10