New Procedure to Reduce Mother-newborn Separation

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Neonatal Disease

Treatments: Procedure: Observation of newborn with respiratory distress in the delivery room

Study type: Interventional

Funder types: Other

Identifiers

NCT06594458

6113

Details and patient eligibility

About

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

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 1 minute to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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142 participants in 1 patient group

Neonatal Respiratory Distress Arm

Experimental group

Description:

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.

Treatment:

Procedure: Observation of newborn with respiratory distress in the delivery room