New Procedure to Reduce Mother-newborn Separation
ConditionNeonatal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Multiple pregnancy
Need for invasive respiratory assistance
Need for resuscitation at birth
Criteria for perinatal asphyxiation
Trial design
Design model
Single group
Treatments tested in this trial
Observation of newborn with respiratory distress in the delivery room
Procedure/SurgeryNewborn 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
Treatment groups
142 Participants
are divided into 1 treatment groupGroup A: Neonatal Respiratory Distress ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Limit the separation between mother and newborn
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
Time frame
3 hoursSecondary outcomes
1
Exclusive Breastfeeding rate
To evaluate improvement in exclusive breastfeeding as a result of the new procedure
Time frame
3 daysSponsors and contacts
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Source ClinicalTrials.gov