Infant, Premature, Diseases Clinical Trial
— MHMHMFOfficial title:
TITLE OF STUDY: Safety and Efficacy of a Novel Human Milk-based Human Milk Fortifier in Very Low Birth Weight Infants
Verified date | April 2024 |
Source | Northwest Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 23 Weeks to 32 Weeks |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Willow Creek Women's Hospital | Johnson | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Northwest Health | Neolac Inc dba Medolac Laboratories |
United States,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weight gain (gm/kg/day) | Weights. | Daily from first day of enrollment until 36 weeks post menstrual age or discharge | |
Secondary | length increment (cm/kg/day) | length | Weekly until 36 weeks post menstrual age or discharge | |
Secondary | Head Circumference increment (cm/kg/day) | Head circumference | Weekly until 36 weeks post menstrual age or discharge | |
Secondary | Volume of Fortifier | Total intake of formula and fortifier | Daily until 36 weeks post menstrual age or discharge | |
Secondary | Morbidity | Adverse Events-necrotizing enterocolitis, retinopathy of prematurity and bronchopulmonary dysplasia. | weekly until 36 weeks post menstrual age or discharge |
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