Efficacy and safety of preterm formula supplemented with energy substrates for the nutrition of infants of very low birth weight

Completed

Conditions: Very low birth weight
Pregnancy and Childbirth
Disorders related to short gestation and low birth weight, not elsewhere classified

Registration Number: ISRCTN61070850

Lead Sponsor: ational Institute of Paediatrics (Instituto Nacional de Pediatria) (Mexico)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 63

Inclusion Criteria

1. Both male and female infants, aged less than 28 days
2. Hospitalised in the Intensive Care Unit (ICU) or Neonatal Intermediate Care Unit (NICU)
3. Weight less than 1500 g at birth
4. Fed exclusively via enteral route
5. Haemodynamic stability (arterio-venous 3 - 5)
6. Have not received prior formulas with added energy substrates
7. Signed informed consent by parents or guardians

Exclusion Criteria

1. Patients suffering from inborn errors of metabolism in any variant or a disease in itself a negative influence on growth (congenital heart disease, kidney failure, genetic diseases)
2. Post-operative state greater than 72 hours

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of days required to reach 1800 g in weight<br>2. Type of treatment administered<br>3. Weight<br>4. Height<br>5. Cephalic perimeter<br>6. Mid-arm circumference<br><br>Measured at 21 days.

Secondary Outcome Measures

Name	Time	Method
1. Biochemical parameters: serum albumin, prealbumin, total protein, creatinine, blood-urea nitrogen (BUN), nitrogen balance<br>2. Security settings: abdominal perimeter, vomiting, stool consistency, temperature, blood in stools, serum glucose, calcium, phosphorus, magnesium, triglycerides<br><br>Measured at 21 days.