New Procedure to Reduce Mother-newborn Separation
Recruiting now · Not applicable
Conditions studied: Neonatal Disease
In brief
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
Key facts
- Study ID
- NCT06594458
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 142
- Starts
- 2023-10-25
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2024-09-19
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants born by elective cesarean section, with gestational age ≥34 weeks, weight at birth ≥2000 grams, manifesting mild respiratory distress with need for oxygen at FiO2 ≤30%
- Signature by both parents of an informed consent
You may not qualify if…
- Multiple pregnancy
- Need for invasive respiratory assistance
- Need for resuscitation at birth
- Criteria for perinatal asphyxiation
- Fetal pathology
- Failure by both parents to sign up for informed consent
Where it is running
- Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia — Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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