An interventional study of Adjustable Human Milk Fortification and Targeted Human Milk Fortification in Growth Failure, sponsored by University of Calgary. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by University of Calgary · Not applicable, Interventional, and Prevention
Research question: Do preterm infants born \<1250 g achieve better weight gain with targeted fortification compared with the adjustable fortification of human milk?
Hypothesis: Targeted fortification of human milk results in better weight gain in infants with birth weight \<1250 gr when compared to the adjustable fortification.
Study design: Open-label, pragmatic, parallel randomized controlled trial in appropriate for gestational age infants with birth weight \<1250 g.
Human milk is the ideal diet for neonates. However, it does not provide enough energy, protein, and sodium to meet the nutritional requirements of very preterm infants. Postnatal growth failure is common despite the current use of human milk fortifiers. The main human milk fortification methods include:
Individualized human milk fortification which encompasses two methods:
SF has frequently failed to achieve appropriate weight gain, while individualized (AF or TF) fortification seems to have better performance. However, the evidence to support one method over the other is lacking.
The objective of the study is to compare weekly average weight gain between preterm infants on AF versus TF.
Once the written consent is obtained, the infant will be randomized to AF or TF. The sequence code will be kept in sequential numbered sealed envelopes. Infants from multiple births will be included as 1 unit and randomized to the same arm of the study.
For patients allocated to the TF group, breast milk will be analyzed twice weekly for energy, protein, and sodium contents. The daily protein, fat, and sodium intakes will be then calculated and optimized to meet the recommended dietary reference intake (DRI) for preterm infants with birth weight \<1250 g.
For patients allocated to the AF group, weekly BUN measurements will be performed. Based on BUN concentrations, the liquid protein will be added to achieve the targeted BUN level. Additional calories will be added using formula if growth is suboptimal or DRI is not met based on the assumed human milk content for protein and energy.
The intervention will last 4-8 weeks. For all patients, the day the first BUN concentration and milk analyses are done will be day 1 of intervention. The following measurements will be performed on days 7-8, 14-16, 21-23, and 28-30 of intervention: Weight (grams), length and head circumference (centimeters), BUN and sodium concentrations.
Data on maternal and neonatal characteristics will be collected from their electronic and physical charts.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's planned enrollment of 52 is below the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Human milk fortification based on blood urea levels
Dietary Supplement: Adjustable Human Milk Fortification
Human milk fortification based on milk analysis
Dietary Supplement: Targeted Human Milk Fortification
BUN and sodium concentrations will be measured every week in infants on full enteral feeds with fortified human milk. Liquid protein will be added based on serum urea.
Human milk will be analyzed twice weekly. Before the day of analysis, each mother will store fresh milk pumped from 10:00 AM until 8:00 AM of the previous day in a refrigerator and bring it to the hospital. Protein, fat, and sodium supplementation will be added to the human milk to meet the recommended daily intakes.
Average weight gain in infants on Adjustable versus Targeted human milk fortification
Average weight gain measured as g/kg per day
Time frame: Weekly for 8 weeks
Anthropometrics in infants on Adjustable versus Targeted human milk fortification
Measurement of head circumference and length in centimeters.
Time frame: Weekly for 8 weeks
BUN concentration in infants on Adjustable versus Targeted human milk fortification
mmol/L
Time frame: Weekly for 4 weeks
Incidence of extra uterine growth restriction
Defined as weight less than 10th percentile at 36 weeks corrected age (CA)
Time frame: At 36 weeks CA
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