Status:
RECRUITING
New Procedure to Reduce Mother-newborn Separation
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Neonatal Disease
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
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 mana...
Detailed Description
This procedure provides that newborn infants, who at 15 minutes of life manifest tachypnea or respiratory distress (that responds to supplementary oxygen with FiO2 \<30% and without the need for mecha...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06594458
Start Date
October 25 2023
End Date
January 31 2027
Last Update
September 19 2024
Active Locations (1)
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1
Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia
Roma, Italy, 00168