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

Efficacy and safety of preterm formula addition with medium chain triglycerides or maltodextrins compared with milk formula without addition of energy substrates for nutrition of newborn very low birth weight: a randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61070850

Enrollment

Registered

2009-06-05

Start date

2007-01-10

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Group 1 (n = 21): Preterm formula without supplements (control group) Group 2 (n = 21): Preterm formula supplemented with maltodextrin (10 kcal/day). The amount of maltodextrin in the formula will be

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026