ActivePhase 3ACTRN12611000247976

Does lactoferrin improve survival free from morbidity in very low birth weight infants? Lactoferrin Infant Feeding Trial: a randomised controlled trial

Does lactoferrin improve survival free from morbidity in very low birth weight infants? Lactoferrin Infant Feeding Trial: a randomised controlled trial


Sponsor

University of Sydney

Enrollment

1,500 participants

Start Date

Jun 18, 2014

Study Type

Interventional

Conditions

Summary

A two arm randomised controlled trial in more than 1500 preterm babies less than 1500 grams to compare standard feeding regimens versus adding BLF to feeds on the incidence of death and major disability in VLBW infants.


Eligibility

Sex: Both males and femalesMax Age: 7 Dayss

Inclusion Criteria1

  • Babies are eligible if (a) <1500 g birth weight (b) less than or equal to 7 days old and expected to survive and (c) parent gives written informed consent.

Exclusion Criteria1

  • Babies with severe congenital anomalies which are likely to cause death are not eligible

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Interventions

Bovine Lactoferrin (BLF): Dosage - 200 mg/kg/day added to breast milk or formula, once daily. Study intervention is administered until 34 weeks corrected gestation or for 2 weeks, whichever is longe

Bovine Lactoferrin (BLF): Dosage - 200 mg/kg/day added to breast milk or formula, once daily. Study intervention is administered until 34 weeks corrected gestation or for 2 weeks, whichever is longer, or until discharge home, if earlier.


Locations(1)

Christchurch; Wellington, New Zealand

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