New procedure to keep mothers and newborns together
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
This study is testing a new way to care for newborns with breathing issues right after birth to see if it helps keep mothers and babies together and supports breastfeeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 1 Minute to 3 Days |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06594458 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to reduce the separation between mothers and their newborns by implementing a new procedure for managing newborns with respiratory distress in the delivery room. Newborns exhibiting mild respiratory distress will be monitored in a preheated incubator and provided with supplemental oxygen if necessary. The study evaluates whether this approach can decrease the need for Neonatal Intensive Care Unit admissions within the first 24 hours of life and improve rates of exclusive breastfeeding. Clinical evaluations will be conducted every 15 minutes to assess the newborn's condition and determine the appropriate course of action.
Who should consider this trial
Good fit: Ideal candidates include infants born by elective cesarean section, at least 34 weeks gestational age, weighing over 2000 grams, and exhibiting mild respiratory distress requiring minimal oxygen.
Not a fit: Patients who may not benefit include those requiring invasive respiratory assistance, resuscitation at birth, or those with multiple pregnancies or perinatal asphyxia.
Why it matters
Potential benefit: If successful, this procedure could enhance mother-newborn bonding and improve breastfeeding rates.
How similar studies have performed: While similar approaches have been explored, this specific procedure is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia — Roma, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.