Neonatal DiseaseNCT06594458
New Procedure to Reduce Mother-newborn Separation
A study testing Observation of newborn with respiratory distress in the delivery room in people with Neonatal Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 3 days
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- Observation of newborn with respiratory distress in the delivery room
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia
Roma, 00168
Francesca Priolo, +390630154357, francesca.priolo@policlinicogemelli.it
Claudia Fe, +390630154357, claudia.fe@policlinicogemelli.it
About this study
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
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:
Read more
- 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
Read the 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
- Being tested
- Observation of newborn with respiratory distress in the delivery room
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of newborn with respiratory distress in the delivery roomProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Neonatal Respiratory Distress Arm | Experimental | 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. Receives: Procedure: Observation of newborn with respiratory distress in the delivery room |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Secondary outcomes (1)
Exclusive Breastfeeding rate
To evaluate improvement in exclusive breastfeeding as a result of the new procedure
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594458
- Sponsor's protocol ID
- 6113
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06594458
- Acronym / sponsor ID
- 6113
- Conditions
- Neonatal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal Respiratory Distress Arm | Experimental | Procedure: Observation of newborn with respiratory distress in the delivery roomNewborn 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. |
Who may qualify
- Ages
- 1 minute to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Multiple pregnancy
- Need for invasive respiratory assistance
- Need for resuscitation at birth
- Criteria for perinatal asphyxiation
- Fetal pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of newborn with respiratory distress in the delivery roomNewborn 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 | Procedure or surgery | Neonatal Respiratory Distress Arm |
Primary outcome
Limit the separation between mother and newborn
Time frame: 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
1 secondary outcome
Exclusive Breastfeeding rate
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fondazione Policlinico Agostino Gemelli IRCCS, UOC Neonatologia
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation of newborn with respiratory distress in the delivery room in people with Neonatal Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limit the separation between mother and newborn (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.