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Study identifier: NCT06594458 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

New Procedure to Reduce Mother-newborn Separation

Condition: Neonatal Disease  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhaseNA
Planned participants142
Who can joinAll sexes, 1 Minute to 3 Days
Healthy volunteersNo

About this study

The goal of this single-centre interventional study without medication neither device (for procedure) is to limit the separation between mother and newborn by implementing a new procedure for the management of the newborn with respiratory distress in the delivery room. The main questions it aims to answer are: * Is it possible to reduce Neonatal Intensive Care Unit admissions within 24 hours of life by applying this new procedure, thus limiting separation between mother and newborn? * Does the implementation of this procedure, reducing mother-newborn separation, improves the rate of exclusive breastfeeding? Newborns with respiratory distress at birth will be evaluated in the delivery room in a dedicated pre-heated incubator, providing additional oxygen if necessary. In case of improvement they will be reunited with the mother, in case of worsening a thoracic ultrasound will be performed to assess the severity and possible hospitalization in Neonatal Intensive Care Unit

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (1)

Fondazione Policlinico Agostino Gemelli IRCCS, UOC NeonatologiaRoma, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06594458