NCT06594458 New Procedure to Reduce Mother-newborn Separation
| NCT ID | NCT06594458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Neonatal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2023-10-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: * 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 Criteria: * 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
Frequently Asked Questions
Who can join the NCT06594458 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 3 Days, studying Neonatal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06594458 currently recruiting?
Yes, NCT06594458 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione Policlinico Universitario Agostino Gemelli IRCCS to inquire about joining.
Where is the NCT06594458 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06594458 clinical trial?
NCT06594458 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 142 participants.