Novel Human Milk Based Human Milk Fortifier

Launched by NORTHWEST HEALTH · Jul 16, 2020

Keywords

ClinConnect Summary

This study is testing a new, human milk–based fortifier added to breast milk to support growth in very premature babies. The main goal is to see how well these babies gain weight (measured daily) when fed human milk with this fortifier, and to monitor their overall growth (length and head size) and how much fortifier they receive. The researchers will also track safety, looking for problems such as infections of the bowel (necrotizing enterocolitis), eye problems (retinopathy of prematurity), or lung issues (bronchopulmonary dysplasia). This is not a randomized trial; all participating babies get the new fortifier and the results will be compared to past babies who received a different fortifier.

Eligible participants are very preterm infants who weigh about 700 to 1,500 grams at birth and are up to 32 weeks gestation. They must start human milk feeding in the NICU and have their mothers commit to feeding human milk exclusively during the study. Twins are allowed, but certain conditions exclude eligibility, such as major congenital problems, severe brain bleeds, recent maternal substance concerns, or major surgery in the baby. The study plans to enroll about 40 babies at Willow Creek Women’s Hospital in Arkansas, with monitoring over roughly 1–8 weeks or until the baby reaches 36 weeks postmenstrual age or discharge.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Birth weight between 750 g-1500 g.
• • ≤ 32 weeks gestational age at birth. GA will be determined by an ultrasound scan or the neonatologist's estimate, with consideration to maternal date.
• • Subject has been classified as appropriate for GA (AGA).
• • Enteral feeding of human milk must be initiated by 21 days of life for infants with a birthweight of 750-1000 g (birth date is day of life 0) and initiated by 14 days of life for infants with a birthweight of 1.0 - 1.5 kg birthweight.
• • Mother agrees to feed the infant human milk as the exclusive feeding during the study period. Human milk may be mothers own or donor milk, plus MHMHMF.
• • Singleton or twin births only.
• Exclusion Criteria:
• • Serious congenital abnormalities or underlying disease that may affect growth and development.
• • 5 minute APGAR: 5 4.
• • Steroids used within the past 5 days
• • Grade Ill or IV periventricular/ intraventricular hemorrhage (PVH/IVH).
• • Maternal cocaine, alcohol or opioid abuse during pregnancy or currently or if the mother or infant is currently receiving treatment for HIV infection.
• • Infant major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
• • Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life.
• • Infant has any other condition that, in the opinion of the investigator, compromises the ability to draw inference about the ability of the MHMHMF to support growth.