Very Low Birth Weight Infant
Conditions
Brief summary
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until the end of the feeding intervention. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.
Detailed description
The end of the feeding intervention is defined as: the infant is 36+0 weeks CA, is discharged home, or receives two oral feeds daily for three consecutive days without top-up. The exception to the 36+0 weeks intervention end-date is in the situation where an infant remains hospitalized but has not completed at least four weeks of the feeding intervention (i.e. 4 weeks following Study Day 1).
Interventions
Standard fortification assumes that the nutrient content of human milk is constant and involves use of a standard fixed dose of multi-nutrient fortifier and as appropriate nutrient modulars.
OTHERTarget fortification
Target fortification involves use of a multi-nutrient fortifier as well as weekly analysis of energy and macronutrients of human milk and subsequent addition of fat and protein modulars if needed.
OTHERBUN adjustable fortification
BUN (blood urea nitrogen) adjustable fortification involves use of a multi-nutrient fortifier as well as weekly BUN tests and subsequent addition of a protein modular according to a prescribed algorithm.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
No
Inclusion criteria
* ≤1250 g birth weight or Gestational Age \<30+0 weeks and \<1500 g birth weight. * Parental/guardian consent to participate. * Consent for the use of pasteurized donor milk if mother's milk is not available.
Exclusion criteria
* Infant received fortifier or formula before Study Day 1. * Study Day 1 anticipated to occur after postnatal day 21. * Infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment. * Enrollment in any other clinical study affecting nutritional management during the feeding intervention. * Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Composite Score | 18-24 months corrected age | Bayley Scales of Infant and Toddler Development |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Language Composite Score | 18-24 months CA | Bayley Scales of Infant and Toddler Development |
| Motor Composite Score | 18-24 months CA | Bayley Scales of Infant and Toddler Development |
| Weight Gain during the intervention | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first | Change in z-score |
| Length gain during the intervention | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first | Change in z-score |
| Head circumference gain during the intervention | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first | Change in z-score |
| Body composition at the end of the intervention | 36 weeks corrected age | Skinfolds |
| Serious Morbidity | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first | Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP) |
| Health Economics | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first | Total cost incurred for in-hospital care |
| Weight at follow-up | 4 months corrected age | z score |
| Length at follow-up | 4 months corrected age | z score |
| Head Circumference at follow-up | 4 months corrected age | z score |
| Body composition at follow-up (approximated) | 4 months corrected age | Skinfolds |
| Body composition at follow-up (direct measurement) | 4 months corrected age | Air displacement plethysmography |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORDeborah O'Connor, PhD RD
The Hospital for Sick Children
PRINCIPAL_INVESTIGATORSharon Unger, MD
Sinai Health System
Outcome results
None listed