Status:
ENROLLING_BY_INVITATION
Novel Human Milk Based Human Milk Fortifier
Lead Sponsor:
Northwest Health
Collaborating Sponsors:
Neolac Inc dba Medolac Laboratories
Conditions:
Infant, Premature, Diseases
Eligibility:
All Genders
23-32 years
Phase:
NA
Brief Summary
The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04478487
Start Date
September 1 2019
End Date
September 30 2024
Last Update
April 17 2024
Active Locations (1)
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1
Willow Creek Women's Hospital
Johnson, Arkansas, United States, 72741