Comparing two methods of fortifying human milk for preterm infants
Effect of Adjustable Versus Targeted Human Milk Fortification on Weight Gain in Preterm Infants With Birth Weight <1250 g: A Randomized Controlled Trial
This study is testing whether a special way of adding nutrients to human milk helps very small preterm babies gain weight better than a different method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT04809350 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether targeted fortification of human milk leads to better weight gain in preterm infants weighing less than 1250 grams compared to adjustable fortification. It is an open-label, pragmatic, parallel randomized controlled trial conducted at Foothills Medical Centre. The study aims to address the common issue of postnatal growth failure in very preterm infants by comparing the effectiveness of two individualized fortification methods. The trial will measure weekly average weight gain to determine which method is more beneficial for these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at Foothills Medical Centre with a birth weight of less than 1250 grams and who are appropriate for gestational age.
Not a fit: Patients with major congenital anomalies, acute kidney injury, or those who develop necrotizing enterocolitis prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve weight gain and overall health outcomes for preterm infants with low birth weight.
How similar studies have performed: While individualized fortification methods have shown promise, this specific comparison between adjustable and targeted fortification is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants with birth weight \<1250 g born at Foothills Medical Centre. * Appropriate for gestational age (AGA) (according to Fenton's Charts). Exclusion Criteria: * Abnormal Newborn Metabolic Screen * Major congenital anomalies intervention. * Patients who develop NEC prior to enrollment. * Patients with confirmed congenital Toxoplasmosis, Syphilis, Rubella, Cytomegalovirus, Herpes simplex virus, Varicella and/or Zika (TORCH infections). * Patients receiving systemic steroids. * Patients with acute kidney injury (AKI).
Where this trial is running
Calgary, Alberta
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Belal Alshaikh, MD, MSc — University of Calgary
- Study coordinator: Belal N Alshaikh, MD, MSc
- Email: balshaik@ucalgary.ca
- Phone: 4039561588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.