New Procedure to Reduce Mother-newborn Separation

NCT ID: NCT06594458

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2027-01-31

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

Detailed Description

This procedure provides that newborn infants, who at 15 minutes of life manifest tachypnea or respiratory distress (that responds to supplementary oxygen with FiO2 <30% and without the need for mechanical ventilation) they 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, such as heart rate, oxygen saturation and respiratory rate. 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 hospitalize the newborn in the Neonatal Care, Neonatal Sub-Intensive Care or Neonatal Intensive care Units.

Conditions

Neonatal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Neonatal Respiratory Distress Arm

Newborn manifesting tachypnea or respiratory distress in the delivery room (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.

Group Type: EXPERIMENTAL

Observation of newborn with respiratory distress in the delivery room

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Francesca Priolo

Role: primary

francesca.priolo@policlinicogemelli.it

+390630154357

Claudia Fe

Role: backup

claudia.fe@policlinicogemelli.it

+390630154357

Other Identifiers

6113

Identifier Type: -

Identifier Source: org_study_id