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Optimising the protein and energy content of human milk feeds to improve the growth of preterm infants - A Randomised Control Trial (RCT)

Targeting human milk fortification to achieve preterm infant growth targets - A RCT

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000443099
Enrollment
40
Registered
2010-06-01
Start date
2009-01-26
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Preterm infants < 30 weeks gestation will be randomised to either receive targeted fortification of human milk based on measured macronutrient composition or routine fortification of human milk based on assumed macronutrient composition. Nutrition intakes, growth and body composition will be the outcome measures.

Interventions

Intervention: Fortifying human milk based on the macronutrient composition of milk, measured using mid-infrared technology. Milk is fortified using human milk fortifier (HMF), a whey protein supplement and a carbohydrate and fat (energy) supplement. The amount of fortifier added to milk feeds depends on the macronutrient composition of the milk and targets recommended protein and energy intakes (Tsang et al. 2005). The intervention is administered throughout the period of time an infant rec

Intervention: Fortifying human milk based on the macronutrient composition of milk, measured using mid-infrared technology. Milk is fortified using human milk fortifier (HMF), a whey protein supplement and a carbohydrate and fat (energy) supplement. The amount of fortifier added to milk feeds depends on the macronutrient composition of the milk and targets recommended protein and energy intakes (Tsang et al. 2005). The intervention is administered throughout the period of time an infant receives fortified feeds. Fortified milk feeds commence at the discretion of the neonatologist, according to the Unit's standard enteral feeding practice, and continue until discharge, unless clinically contraindicated. Standard enteral feeding practice incorporates 3 stages and two levels of feeds: Stage 1. Unfortified milk is fed until infants tolerate between 100 and 150 mL/kg/d. Stage 2. Milk is fortified to Level 1 - this level targets recommended protein and energy intakes within volumes of 160-180 mL/kg/d. Stage 3. (only for fluid restricted infants who are tolerating Level 1, who receive less than or equal to 150 mL/kg/d and who demonstrate poor growth). Milk is fortified to Level 2 - this level targets recommended protein and energy intakes within volumes of 130-150 mL/kg/d. REFERENCE Tsang RC, Uauy R, Koletzko B, Zlotkin SH (eds). Nutrition of the preterm infant. Scientific basis and practical guidelines. 2nd Ed. Cincinnati, Ohio: Digital Educational Publishing.

Sponsors

The University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
23 Weeks to 29 Weeks
Healthy volunteers
No

Inclusion criteria

Preterm infants < 30 weeks gestation

Exclusion criteria

Infants born with congenital abnormalities. Maternal intention to formula feed. Living outside the metropolitan area (if this results in the infant being unable to attend the term follow-up assessment).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026