Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594458
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-10-23
Brief Title:
New Procedure to Reduce Mother-newborn Separation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
To Reduce the Separation of the Mother-newborn Dyad in the First Day of Life Through the Implementation of a New Procedure in the Delivery Room
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None