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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

• Study Contact: Name: Sabrina GOUDJIL, Ph; Phone Number: +33 0322087741; Email: goudjil.sabrina@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • CHU Amiens-Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardio-respiratory coordination index	Percentage of time during the recording that fulfills the criteria of coordination ( > 0.7 amplitude of spectra in coordigram)	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardio-respiratory coordination index by phase analysis technique	10 days
Correlation between cardio-respiratory coordination index and SaO2	10 days
Correlation of temperatures (infant, parent) and cardio-respiratory coordination index	10 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): September 12, 2020

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PI2017_843_0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No