DoMINO

RESEARCH QUESTIONS

Primary Research Question: Does use of donor milk compared to preterm formula as a supplement to mother's milk for the first 90 days after randomization or until hospital discharge, whichever comes first, improve cognitive development of VLBW infants at 18 months corrected age (CA)?
Secondary Research Questions: Does use of donor milk compared to preterm formula as a supplement to mother's milk for the first 90 days after randomization or until hospital discharge, whichever comes first:
(i) reduce neonatal mortality and morbidity?
(ii) support growth?
(iii) improve language and motor development at 18 months CA?
(iv) improve visual development at 4 and 6 months CA?
Exploratory Research Questions: Does use of donor milk compared to preterm formula as a supplement to mother's milk for the first 90 days after randomization or until hospital discharge, whichever comes first:
(i) influence feeding tolerance and nutrient intake?
(ii) show an acceptable cost effectiveness from a societal perspective?

STUDY DESIGN

This is a multi-centre, intent-to-treat, double blinded, randomized controlled trial of the effectiveness of donor milk.  Three hundred and fifty-two VLBW infants will be randomized within four days of life to receive either donor milk or preterm formula when mother's milk is unavailable for 90 days after randomization or discharge home, whichever occurs first.  Data on mortality, morbidity, growth, feeding tolerance, and nutrient intake will be collected prospectively.  Families will be contacted bi-weekly to ascertain feeding practices and healthcare resources accessed on behalf of their child.  Cognitive, language, motor, and visual development and growth measurements will be collected at 4, 6, 12, and 18 months CA corresponding to important feeding, growth and developmental milestones and routine clinics visits.  A non-invasive sweep visual evoked potential procedure will be used to assess the visual acuity and contrast sensitivity of infants at 4 and 6 months CA.  Infants will be tested on the Bayley Scales of Infant and Toddler Development (BSID-III) at 18 months CA which is a standardized test designed to assess the cognitive, language (receptive, expressive) and motor (fine, gross) development of infants. http://www.controlled-trials.com/ISRCTN35317141

 

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