New Procedure to Reduce Mother-newborn Separation
ConditionNeonatal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Multiple pregnancy
Need for invasive respiratory assistance
Need for resuscitation at birth
Criteria for perinatal asphyxiation
Trial design
Treatments tested in this trial
- Observation of newborn with respiratory distress in the delivery room
Treatment groups
142 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov