Actively Recruiting
To Reduce the Separation of the Mother-newborn Dyad in the First Day of Life Through the Implementation of a New Procedure in the Delivery Room
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-19
142
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a new procedure to reduce separation between mother and newborn infants with respiratory distress shortly after birth. The study focuses on newborns who show mild respiratory issues that respond to low levels of supplemental oxygen, seeking to see if this approach can lower Neonatal Intensive Care Unit admissions within the first 24 hours and improve exclusive breastfeeding rates. Newborns who develop respiratory distress within 15 minutes of life and respond to oxygen levels below 30% without needing mechanical ventilation are placed in a preheated incubator. They are closely monitored with clinical evaluations every 15 minutes including vital signs like heart rate and oxygen saturation. If the newborn improves and oxygen therapy stops, they move to a Neonatal Observation Ward for monitoring up to 6 hours before reuniting with their mother. If the condition worsens, a bedside thoracic ultrasound guides decisions on continued observation or admission to various neonatal care units. Participants will be observed and have vital signs measured regularly during their stay in the delivery room and observation ward. The study measures how well the procedure limits mother-newborn separation during the first 3 hours of life, as well as the rate of exclusive breastfeeding at 3 days. Close monitoring and ultrasound assessments support decisions about care level and hospitalization, aiming to enhance early mother-infant bonding and health outcomes.
CONDITIONS
Brief Title
New Procedure to Reduce Mother-newborn Separation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born by elective cesarean section
- Gestational age of 34 weeks or more
- Birth weight of at least 2000 grams
- Mild respiratory distress requiring oxygen at FiO2 30% or less
- Signed informed consent 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 of both parents to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 hours of life
Newborns with mild respiratory distress are placed in a preheated incubator with oxygen if needed and carefully monitored by medical and nursing clinicians. Clinical evaluations with vital signs are done every 15 minutes. Based on the baby's condition, newborns may be transferred for further monitoring or care.
Continuous monitoring during initial 6 hours after birth
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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