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Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care (PO-A-PO-PREMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827252
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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.

Condition or disease
Premature Infant

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.

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Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Cardio-respiratory coordination index by phase analysis technique [ Time Frame: 10 days ]
  2. Correlation between cardio-respiratory coordination index and SaO2 [ Time Frame: 10 days ]
  3. Correlation of temperatures (infant, parent) and cardio-respiratory coordination index [ Time Frame: 10 days ]


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Ages Eligible for Study:   28 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827252


Contacts
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Contact: Sabrina GOUDJIL, Ph 0322087741 ext +33 goudjil.sabrina@chu-amiens.fr

Locations
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France
CHU Amiens-Picardie Recruiting
Amiens, France, 80000
Contact: Sabrina GOUDJIL, Ph    0322087741 ext +33    goudjil.sabrina@chu-amiens.fr   
Principal Investigator: Sabrina GOUDJIL, Ph         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03827252    
Other Study ID Numbers: PI2017_843_0008
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications