New Procedure to Reduce Mother-newborn Separation

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Eligibility

Primary outcome measure(s)

• Limit the separation between mother and newborn — 3 hours
  Newborn manifesting respiratory distress at birth are placed in a preheated incubator with the required oxygen concentration (if necessary). 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 it will be evaluated whether to continue the observation in the delivery room or to admit the newborn in the Neonatal Care or Neonatal Intensive care Units

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy