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

Congenital Heart Disease Clinical Trial

— CHD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389491
• Other study ID #: FNF201426
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: November 9, 2015
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Dietary Supplement:
• normal density formula (Necocate)
In control group,there are 32 infants
• high density formula(Infatrini)
In intervention group,there are 32 infants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain at the 7th day (g)	the 7th day body weight minus baseline body weight	from the first day starting enteric feeding to the 7th days	No
Primary	the number of participants with feeding intolerance	Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped.	from the first day starting enteric feeding to the 7th day	Yes
Secondary	Duration of mechanical ventilation	evaluate the long term effect of feeding high density formula	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	length of Cardiac Intensive Care Unit(CCU) stay	evaluate the long term effect of feeding high density formula	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	the number of participants with poor wound healing	evaluate the long term effect of feeding high density formula	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	the number of participants with necrotizing enterocolitis	evaluate the long term effect of feeding high density formula	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes