Novel Human Milk Based Human Milk Fortifier

Launched by NORTHWEST HEALTH · Jul 16, 2020

Keywords

ClinConnect Summary

Background Once feeding low birthweight (LBW) or very low birthweight (VLBW) infants was primarily by commercial specialty formulas. As public health emphasis on breastfeeding increased awareness and prevalence of breastfeeding, the use of human milk in the Neonatal Intensive Care unit (NICU) became more common. However, despite the fact that milk from mothers delivering prematurely has higher nutritional content than milk from mothers delivering at term, mainly in protein and fat, thus calories, nutrient intake from human milk alone is not sufficient to satisfy the nutrition of the LBW or ...

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.