Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)

Launched by THE HOSPITAL FOR SICK CHILDREN · Mar 31, 2022

Keywords

ClinConnect Summary

The MaxiMoM-InForM study is looking at how to provide the best nutrition for very low birth weight infants, specifically those born weighing 1250 grams or less. These babies have special nutritional needs, and while extra nutrients are usually added to their human milk feeds, many still struggle with growth and development after leaving the hospital. This trial will compare three different methods of fortifying human milk—one standard method and two individualized approaches—to see which one better supports the babies' growth and health during their hospital stay.

To participate in this study, infants must weigh 1250 grams or less at birth, and caregivers need to give consent for their participation. The study will randomly assign babies to receive milk fortified in one of the three methods until they reach 36 weeks of age or are discharged from the hospital. Throughout the trial, researchers will monitor the babies' growth and health, and later assess their development when they are 18 to 24 months old. This research aims to find the most effective way to support these vulnerable infants and their families.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≤1250 g birth weight or Gestational Age \<30+0 weeks and \<1500 g birth weight.
• • Parental/guardian consent to participate.
• • Consent for the use of pasteurized donor milk if mother's milk is not available.
• Exclusion Criteria:
• • Infant received fortifier or formula before Study Day 1.
• • Study Day 1 to occur after postnatal day 21.
• • Infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment.
• • Enrollment in any other clinical study affecting nutritional management during the feeding intervention.
• • Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention.