Actively Recruiting

Phase Not Applicable
Age: 1Minute - 3Days
All Genders
ID06594458

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

Age: 1Minute - 3Days
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observation

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

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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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