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Optimization of Early Postnatal Weight Monitoring in Newborns: Implementation and Evaluation of an Additional Weight Measurement at 24 Hours for More Accurate Determination of Reference Weight

Optimization of Early Postnatal Weight Monitoring in Newborns: Implementation and Evaluation of an Additional Weight Measurement at 24 Hours for More Accurate Determination of Reference Weight

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039265
Enrollment
1280
Registered
2026-07-13
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postnatal weight loss in newborns

Interventions

Group 1: Newborns = 35+0 weeks of gestation who are born between February 2026 and May 2026 at LMU University Hospital (Campus Großhadern and Campus Innenstadt) and are transferred to the postnatal wa
clinical management (breastfeeding management, decisions regarding supplementary feeding, clinical monitoring) remains unchanged. Observation period per newborn: from birth until at least 48 hours pos

Sponsors

Klinik und Poliklinik für Kinderheilkunde, Neonatologie, Standort Großhadern Ludwig-Maximilians-Universität München
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Newborns with a gestational age = 35+0 weeks, born at LMU University Hospital (Campus Großhadern or Campus Innenstadt) between February 2026 and May 2026, and transferred to a postnatal ward after birth. Documentation of weight measurements according to the study protocol (= 4 hours, 20–30 hours, and 48 hours postpartum).

Exclusion criteria

Exclusion criteria: Preterm newborns with a gestational age < 35+0 weeks and newborns who are transferred primarily or secondarily to a neonatal intensive care or intermediate care unit after birth.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the percentage weight loss within the first 48 hours of life in newborns = 35+0 weeks of gestation. Weight loss is calculated as the difference between the body weight at 48 hours of life and the reference weight measured at 20–30 hours postpartum, relative to the weight measured at 20–30 hours postpartum. The parameter is determined once per newborn after the 48-hour weight measurement has been obtained. Weight data are collected as part of routine clinical care and through the additional study-related weight measurement at 20–30 hours postpartum using standardized, calibrated clinical infant scales. Data are extracted from the electronic medical record.

Secondary

MeasureTime frame
Secondary endpoints include: - Frequency of supplementary feeding within the first 48 hours of life - Change in classification of clinically relevant weight loss (e.g., > 7%) when using different reference weights (= 4 hours vs. 20–30 hours postpartum) - Detailed weight trajectory between birth, = 4 hours, 20–30 hours, and 48 hours postpartum - Feasibility of implementing the additional weight measurement in routine clinical practice Data will be obtained from the electronic medical record and routine clinical documentation.

Countries

Germany

Contacts

Public ContactTeresa Starrach

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Campus Großhadern, Ludwig-Maximilians-Universität München

Teresa.starrach@med.uni-muenchen.de+49 89/ 4400 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026