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Improving the growth and development of preterm infants. Comparison of a fortifier prepared from donor breast milk with standard fortifiers used in routine practice. - A multicenter, randomized, clinical trial -

Improving the growth and development of preterm infants. Comparison of a fortifier prepared from donor breast milk with standard fortifiers used in routine practice. - A multicenter, randomized, clinical trial -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032175
Enrollment
240
Registered
2023-07-21
Start date
2023-08-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Postnatal growth restriction, feeding tolerance

Interventions

Group 1: Breast milk fortification with a fortifier based on donor's milk Group 2: Breast milk fortification with the current standard fortifier

Sponsors

Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg, Klinik für Neugeborene, Kinder und Jugendliche
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Preterm infants receiving fortified breast milk.

Exclusion criteria

Exclusion criteria: -Gastrointestinal malformation, severe congenital anomalies, and chromosomal abnormalities; -Preterm infants with enterostomy or short bowel syndrome; -Sepsis - All infants with gram-negative sepsis are excluded for per protocol analysis. -Necrotizing enterocolitis defined by food intolerance associated with positive radiographic findings (pneumatosis intestinalis - Bell stage 2; air in the biliary tract or free air in the peritoneum - Bell stage 3).

Design outcomes

Primary

MeasureTime frame
Weight measured with a scale at a postmenstrual age of 36 weeks

Secondary

MeasureTime frame
Growth, nutritional intake, feeding tolerance, clinical chemstry, morbidity, length of stay

Countries

Germany

Contacts

Public ContactChristoph Fusch

Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg, Klinik für Neugeborene, Kinder und Jugendliche

christoph.fusch@klinikum-nuernberg.de+499113982307

Outcome results

None listed

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