Premature InfantPO-A-PO-PREMANCT03827252
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
An observational study of Premature Infant, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during SSC between the preterm infant and his (her) parent. Read more about this study
- Who is it for?
- Ages 28 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infant
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2018to 12 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 28 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
Who may be able to join
- Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
- At least 72 hours postnatal age
- Benefiting skin-to-skin care
Who cannot join
- Severe congenital malformation and nervous system dysfunction (e.g., Ondine Sd)
- Septic shock
- Mechanical ventilation support
- Severe pulmonary arterial hypertension
- Analgesia morphinics at high dosage and curare
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Respiratory Stability Mechanisms During Skin-to-skin Care in Premature Infants in the Neonatal Intensive Care Unit: Infant-parent Vegetative Functions Coupling
The main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during SSC between the preterm infant and his (her) parent.
Read the detailed description
The skin to skin care (SSC) is a technique that proceeds by laying the neonate ventrally on the parent's chest. Many positive effects are recognized as due to SSC i.e, maintaining the infant's body temperature, better sleep organization, neurocognitive development and cardio-respiratory stability, more strength in parent-infant affective relations, reduction in neonatal and parental stress, more success in feeding with breast milk. Nowadays, SSC is generalized in modern Neonatal Intensive Care Units as part of developmental care. However, the mechanisms involved in SSC are not totally understood. The hypothesis in this study is that the cardio-respiratory stability results partially from the intervention of the coordination between cardiac and respiratory activities. These suppose the involvement of complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers, ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung effectors. In this study the identification of these characteristics will be performed by processing signals of ECG, SaO2 (arterial oxygen saturation), respiratory movements, perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring systems. Each preterm infant included in the study will be explored twice, 5-10 days apart. The explorations will be carried out on 3 steps: before (at least 30 minutes), during (at least 60 minutes) and after (≥ 60 minutes) the SSC session. Each patient will participate in the study for 10 days at maximum. Inclusions in the study will last for a total period of 18 months and 10 days. The cardio-respiratory coordination will be assessed using coordigram technique, corresponding to the proportion of time with > 0.7 amplitude on spectral density.
- Conditions
- Premature Infant
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-respiratory coordination index
Percentage of time during the recording that fulfills the criteria of coordination ( > 0.7 amplitude of spectra in coordigram)
Measured: 10 days
Secondary outcomes (3)
Cardio-respiratory coordination index by phase analysis technique
Measured: 10 days
Correlation between cardio-respiratory coordination index and SaO2
Measured: 10 days
Correlation of temperatures (infant, parent) and cardio-respiratory coordination index
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start7 Sep 2018
- Primary completion11 Dec 2019
- Study completion12 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827252
- Sponsor's protocol ID
- PI2017_843_0008
- Acronym
- PO-A-PO-PREMA
- Status last verified
- May 2023
- First submitted
- 31 Jan 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Respiratory Stability Mechanisms During Skin-to-skin Care in Premature Infants in the Neonatal Intensive Care Unit: Infant-parent Vegetative Functions Coupling
- ClinicalTrials.gov ID
- NCT03827252
- Acronym / sponsor ID
- PO-A-PO-PREMA / PI2017_843_0008
- Conditions
- Premature Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 1 Feb 2019 (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 main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during SSC between the preterm infant and his (her) parent.
Detailed description
The skin to skin care (SSC) is a technique that proceeds by laying the neonate ventrally on the parent's chest. Many positive effects are recognized as due to SSC i.e, maintaining the infant's body temperature, better sleep organization, neurocognitive development and cardio-respiratory stability, more strength in parent-infant affective relations, reduction in neonatal and parental stress, more success in feeding with breast milk. Nowadays, SSC is generalized in modern Neonatal Intensive Care Units as part of developmental care. However, the mechanisms involved in SSC are not totally understood. The hypothesis in this study is that the cardio-respiratory stability results partially from the intervention of the coordination between cardiac and respiratory activities. These suppose the involvement of complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers, ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung effectors. In this study the identification of these characteristics will be performed by processing signals of ECG, SaO2 (arterial oxygen saturation), respiratory movements, perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring systems. Each preterm infant included in the study will be explored twice, 5-10 days apart. The explorations will be carried out on 3 steps: before (at least 30 minutes), during (at least 60 minutes) and after (≥ 60 minutes) the SSC session. Each patient will participate in the study for 10 days at maximum. Inclusions in the study will last for a total period of 18 months and 10 days. The cardio-respiratory coordination will be assessed using coordigram technique, corresponding to the proportion of time with > 0.7 amplitude on spectral density.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
Key inclusion criteria (3 listed)
- Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
- At least 72 hours postnatal age
- Benefiting skin-to-skin care
Key exclusion criteria (5 listed)
- Severe congenital malformation and nervous system dysfunction (e.g., Ondine Sd)
- Septic shock
- Mechanical ventilation support
- Severe pulmonary arterial hypertension
- Analgesia morphinics at high dosage and curare
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardio-respiratory coordination index
Time frame: 10 days
Percentage of time during the recording that fulfills the criteria of coordination ( > 0.7 amplitude of spectra in coordigram)
3 secondary outcomes
Cardio-respiratory coordination index by phase analysis technique
Time frame: 10 days
Correlation between cardio-respiratory coordination index and SaO2
Time frame: 10 days
Correlation of temperatures (infant, parent) and cardio-respiratory coordination index
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 10 May 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardio-respiratory coordination index (time frame: 10 days). 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 10 May 2023.