New Procedure to Reduce Mother-newborn Separation

NARecruitingINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

October 25, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

January 31, 2027

Conditions
Neonatal Disease
Interventions
PROCEDURE

Observation of newborn with respiratory distress in the delivery room

Newborn manifesting tachypnea or respiratory distress at birth (that responds to supplementary oxygen with FiO2 \<30% and without the need for mechanical ventilation) are placed in a preheated incubator with the required oxygen concentration (if necessary) and carefully monitored by medical and nursing clinicians. A clinical evaluation will be carried out every 15 minutes, with the detection of vital parameters. In case of clinical improvement and suspension of oxygen therapy, the newborn will be transferred to the Neonatal Observation Ward to perform multiparameter monitoring of vital signs up to 6 hours of life and then be reunited with the mother. In case of clinical worsening, a bedside thoracic ultrasound will be carried out and depending on the result and the lung ultrasonography score, it will be evaluated whether to continue the observation in the delivery room or to admit the newborn in the Neonatal Care, Neonatal Sub-Intensive Care or Neonatal Intensive care Units

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER