Effects of feeding during the first months of life in post-natal health in babies born small for gestational age (SGA)

Influence of early feeding in subsequent cardiovascular risks in infants born small for gestational age: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36204907

Enrollment

140

Registered

2008-12-23

Start date

2008-06-10

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

Small for gestational age (SGA), adipokines, cardiovascular risk factors Pregnancy and Childbirth Slow foetal growth and foetal malnutrition

Interventions

Newborns born SGA who will not be breastfed will be randomised to receive a regular or an enriched formula for 4 months. Assessments at birth, 15 days, 4, 12 and 24 months (sampling, dual energy X-ray

carhohydrates: 55.0 g%

proteins: 11.7 g% Enriched formula: Fat: 24.7 g%

carbohydrates: 54.9 g%

proteins: 14.5 g% Feeding is ad libitum and following the recommendations of the primary care paediatricians. This is usually every 3 hours the first month, and every 4 hours thereafter. No additional

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Maternally uncomplicated pregnancy (no gestational diabetes, no pre-eclampsia, no use of alcohol, drugs or illicit substances), with delivery at Hospital Sant Joan de Déu in Barcelona 2. Birthweight AGA (between -1 and +1 SD) or SGA (between 1.8 kg and -2 SD) after a term gestation (37 - 42 weeks) 3. Availability of cord serum 4. Ethnically Catalan background

Exclusion criteria

Exclusion criteria: 1. Dysmorphic features 2. 10-minute Apgar score below 7

Design outcomes

Primary

Measure	Time frame
Body composition at age 15 days and at age 4, 12 and 24 months (DXA).	—

Secondary

Measure	Time frame
1. Insulin 2. IGF-1 3. Adipokines 4. Visceral fat Measured in cord blood, and in fasting samples at age 4, 12 and 24 months.	—

Countries

Spain

Outcome results

None listed

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