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Clinical Trials/DRKS00032175
DRKS00032175
Not yet recruiting
未知

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

Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg, Klinik für Neugeborene, Kinder und Jugendliche0 sites240 target enrollmentJuly 21, 2023
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ConditionsPostnatal growth restriction, feeding tolerance

Overview

Phase
未知
Intervention
Not specified
Conditions
Postnatal growth restriction, feeding tolerance
Sponsor
Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg, Klinik für Neugeborene, Kinder und Jugendliche
Enrollment
240
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 21, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants receiving fortified breast milk.

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\).

Outcomes

Primary Outcomes

Not specified

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