Actively Recruiting
New Procedure to Reduce Mother-newborn Separation
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-19
142
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
New Procedure to Reduce Mother-newborn Separation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born by elective cesarean section with gestational age 34 weeks or more
- Birth weight of 2000 grams or more
- Mild respiratory distress requiring oxygen at FiO2 30% or less
- Informed consent signed by both parents
You will not qualify if you...
- Multiple pregnancy
- Need for invasive respiratory assistance
- Need for resuscitation at birth
- Criteria for perinatal asphyxiation
- Fetal pathology
- Failure by both parents to sign informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia
Roma, Italy, 00168
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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