Skip to content

Macronutrient analysis of human milk: the HM+ study Study protocol

Macronutrient analysis of human milk: the HM+ study Study protocol - HM+ study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032331
Enrollment
50
Registered
2025-05-28
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failure to thrive

Interventions

Group 1: Human milk is the recommended diet for preterm infants. Due to the rapid growth and energy requirements of preterm infants, human milk alone is not sufficient to support their growth at the s

Sponsors

Klinikum der LMU München, Neonatologie der Kinderklinik
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterms < 28 weeks GA and Preterms < 1250g who receive standard fortified breast milk are included

Exclusion criteria

Exclusion criteria: - Infants with known congenital anomalies or metabolic disorders - Infants that have already obtained fortified breastmilk for more than 5 days when transferred to NICUs of the LMU Hospital - Infants of parents who are not planning or cannot provide human milk - Infants who have or develop severe complications, e.g.NEC, so that enteral feeding and/or fortification is interrupted (on 3 or more days less than 115/kcal/kg/day enteral energy intake) which would significantly affect growth (Study aim 2) - Infants who are also fed with formula once the measurement period started due to insufficient amount of mother’s own milk (more than 10% of the enteral intake on three days or more during the measurement period).

Design outcomes

Primary

MeasureTime frame
Macronutrient content (carbohydrates, protein, fat) in the administered breast milk or donor milk.

Secondary

MeasureTime frame
Compare the growth of preterm infants whose macronutrient intake through standard fortification meets the ESPGHAN recommendations to those preterm infants whose nutritional levels fall outside the recommendations due to human milk composition being below reference values.

Countries

Germany

Contacts

Public ContactCarmen Jakubowicz

Klinikum der LMU München, Neonatologie der Kinderklinik

Carmen.Jakubowicz@med.uni-muenchen.de49 (0)89 4400 72807

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026