Trials / Unknown
UnknownNCT02865941
Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?
Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- McMaster Children's Hospital · Academic / Other
- Sex
- All
- Age
- 29 Weeks
- Healthy volunteers
- Not accepted
Summary
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth. The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Fortification with modular protein | Modular product supplementation is based on most recent breast analysis done for the participant. |
| DIETARY_SUPPLEMENT | Fortification with modular carbohydrate | Modular product supplementation is based on most recent breast analysis done for the participant. |
| DIETARY_SUPPLEMENT | Fortification with modular fat | Modular product supplementation is based on most recent breast analysis done for the participant. |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-06-01
- Completion
- 2019-06-01
- First posted
- 2016-08-15
- Last updated
- 2016-08-15
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02865941. Inclusion in this directory is not an endorsement.