SUPFOR breast milk study: a randomised controlled trial in preterm infants receiving expressed breast milk comparing the use of breast milk fortification versus supplementation using a preterm formula

SUPFOR breast milk study: a randomised controlled trial in preterm infants receiving expressed breast milk comparing the use of breast milk fortification versus SUPplementation using a preterm FORmula

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92790284

Enrollment

100

Registered

2007-07-04

Start date

2006-04-01

Completion date

Unknown

Last updated

2017-02-27

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

Conditions

Nutrition in preterm infants Nutritional, Metabolic, Endocrine Preterm nutrition

Interventions

Groups are minimised on: 1. Growth retarded less than 10 cm 2. Multiple pregnancy 3. Gestation greater than 31 weeks Interventions: Formula supplement (control): 50% of total enteral feeds are prov

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm infants (less than 35 weeks gestation) 2. Receiving maternal breast milk

Exclusion criteria

Exclusion criteria: Infants who have already received fortification or supplementation (except where this was used in place of inadequate breast milk supply).

Design outcomes

Primary

Measure	Time frame
1. Weight gain (g/day) during initial hospital stay, measured three times a week 2. Length gain (mm/week) and head growth (mm/week) during initial hospital stay, measured once a week 3. Duration and amount of breast milk provided, measured daily	—

Secondary

Measure	Time frame
1. Maternal satisfaction, measured weekly and then at discharge 2. Incidence of abnormal biochemistry, measured when samples are taken - usually once a week	—

Countries

United Kingdom

Outcome results

None listed

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