Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
-
- STATUS
- Recruiting
-
- participants needed
- 200
-
- sponsor
- Crouse Hospital
Summary
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
Description
II. BACKGROUND
While the prevention of feeding related morbidities such as NEC is paramount, growth remains
a concern in these extremely preterm infants. Growth velocity has been shown to have a
significant effect on neurodevelopmental outcomes in at least one study. Human milk
fortifiers are marketed and used to various degrees in an effort to
In summary:
- Exclusive use of human milk is associated with a lower rate of NEC.
- Preterm human milk (maternal or preterm donor) has distinct advantages over commercial donor human milk that comes from mothers of mature term infants.
- Fostering more rapid growth seems advantageous, but the role of fortification in the development of NEC and other morbidities is unclear as are the long term benefits.
Therefore, the purpose of our study is to compare an exclusive preterm human milk diet using routine early fortification with a diet that uses fortification selectively for poor growth.
III. SPECIFIC OBJECTIVES
- To compare the effectiveness of early routine human milk nutritional fortification vs. selective fortification on in-hospital growth in extremely preterm infants.
- To compare the incidence of feeding intolerance and NEC in extremely preterm infants
receiving early routine fortification vs. those receiving selective fortification for
poor
weight gain . - To compare the effect of early routine human milk nutritional fortification vs. selective fortification on growth after discharge from the NICU up to 2 years of age.
- To compare the effect of early routine human milk nutritional fortification vs. selective fortification on neurodevelopmental outcomes at 2 years of age.
IV. STUDY DESIGN
This is a randomized controlled trial in extremely preterm infants, which will be conducted
at the Crouse Hospital NICU in Syracuse, NY. Parents of eligible infants will be approached
by study investigators for informed consent prior to the initiation of
- Early routine fortification (RF): HMDF added to preterm human milk (maternal or donor) when feeds of 150 mL/kg/day are reached.
- Selective fortification (SF): HMDF added to preterm human milk only for
weight gain <15 g/kg/d after full feeds of 180 mL/kg/day are achieved.
Full feeds (120Kcal/kg/day) is achieved with unfortified milk at a volume of 180 ml/kg/day and with fortified human milk at a volume of 150ml/kg/day.
Secondary outcomes will include NEC, time to full feeds (surrogate for feeding intolerance),
other growth parameters (length and head circumference), and neurodevelopmental outcomes at
24 months of age, adjusted for
V. SUBJECT SELECTION Inclusion Criteria: This study will include all extremely preterm
infants with
Exclusion Criteria: Infants with severe
VI. STATISTICAL METHODS, DATA ANALYSIS, AND INTERPRETATION Parametric data will be analyzed using the student t-test and presented with means and standard deviations. Non-parametric data will be analyzed using the Mann-Whitney U-test and presented with medians and interquartile ranges (IQR). Categorical data will be analyzed using the Chi-squared or Fischer's exact test. Weight growth velocities will be calculated using an exponential model validated by Patel et al. from regained birth weight to discharge. Absolute measures of growth (weight, length, head circumference) will be converted to Z-scores using a research calculator (http://www.ucalgary.ca/fenton) based on parameters from the Fenton Preterm Growth Chart.
Z-scores for growth parameters at six-months and 24 months will be calculated based on data from the World Health Organization growth charts (http://www.peditools.org/growthwho/index.php).
VII. STUDY PROCEDURES Feeding Protocol Both
Initiation of trophic feeds with MBM or preterm donor milk (PDM) will be started seven days
after birth and continued at 12 mL/kg/day for one week in both groups. Infants are fed by
After trophic feedings are completed, milk intake is advanced by 15 mL/kg/day as tolerated to
a volume of 150 mL/kg/d. Infants in the RF group will be started on Prolacta HMDF to achieve
milk with 24 kcal/oz and maintained at an intake of 150 mL/kg/day (120 kcal/kg/day). Infants
in the SF group will have human milk increased to 180 mL/kg/day (120 kcal/kg/day) and
maintained at this volume unless fortification is required. If
Per our NICU's current standard of care, feedings will be decreased or stopped for
In the case of a
Infants in the study will have daily weight checks, along with weekly recumbent length measurements and head circumference measurements. These growth parameters will be followed until 35 weeks adjusted age, which is the earliest infants can be discharged home from our NICU. In case infants are transferred to an outlying NICU prior to discharge, growth parameters will continue to be followed at the accepting hospital. After 35 weeks adjusted age, infants will be fed maternal milk if available or a preterm infant formula.
Data Collection In addition to the growth data described above, baseline patient
demographics, clinical characteristics, nutrition information, and NICU outcomes will be
collected on all patients. The demographics and characteristics will include birth weight,
Follow-Up Infants will be seen in our NICU Follow-up clinic at six months, 15 months, and 24 months adjusted age, which is our current standard of care. At these visits, a health history including hospitalizations and diet will be collected. Growth parametersweight, length, and head circumferencewill be measured and a neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development will be administered. Developmental assessments are conducted by staff blinded to prior feeding history.
Data & Safety An independent safety monitoring committee composed of an attending neonatologist (Dr. Ellen Bifano) and milk bank personnel will meet after the first 20 patients are enrolled and periodically to monitor safety during the study. Specifically, feeding related morbidities like NEC will be followed.
All study data will be compiled into an electronic database, which will be kept in a secure password-protected computer in the principal investigator's locked office on the ninth floor of Crouse Hospital. The study subjects' personal health information including name, date of birth, and medical record numbers will be used to identify subjects, and their study information will be part of their medical record. A copy of the data collection form and data analysis form will be submitted along with this protocol and application.
Details
Condition |
|
---|---|
Age | 1years or below |
Treatment | Routine vs Selective use of Human Milk Donor Fortifier |
Clinical Study Identifier | NCT04284280 |
Sponsor | Crouse Hospital |
Last Modified on | 19 February 2024 |
How to participate?
,
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy AnnotationsStudy Notes
Enable the functional cookies in order to view/reply the sharedadd your annotations.
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Publish Annotation
Are you sure you want to publish the annotation?
Delete AnnotationNote
Are you sure you want to delete the annotationnote?
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.