Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking

Overview

The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions. Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).

Full Title of Study: “Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking : A Controlled Randomized Single-center Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2015

Detailed Description

The investigators want to show that the short term autonomic nervous system (ANS) response, after a nociceptive action in the new-born in maternity depends on whether it is preceded by non-nutritive sucking and / or sucrose administration.

Interventions

  • Drug: Glucose sucking
  • Drug: Water sucking
  • Other: No sucking

Arms, Groups and Cohorts

  • Experimental: Glucose sucking
    • The newborn will receive one minute before the painful care either a compress with sucrose. The puncture made in the veins of the back of the hand, will be performed only once per patient per test. Glucose 30% by oral route (1 ml).
  • Active Comparator: Water sucking
    • The newborn will receive one minute before the painful care either a compress with water. The puncture made in the veins of the back of the hand, will be performed only once per patient per test. Sterile water by oral route (1 ml).
  • Placebo Comparator: No sucking
    • The puncture made in the veins of the back of the hand, will be performed only once per patient per test.

Clinical Trial Outcome Measures

Primary Measures

  • High frequency normalized index (HFnu)
    • Time Frame: From 15 min before the painful care to 15 min after.
    • It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor.

Secondary Measures

  • Low frequency (LF and LFnu),
    • Time Frame: From 15 min before the painful care to 15 min after.
    • It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
  • Scale of hetero-assessment of pain (DAN)
    • Time Frame: 15 minutes after the painful care
    • The DAN scale is specific to acute pain of the newborn
  • Electro acoustical characteristic of crying newborn : Duration
    • Time Frame: From 15 min before the painful care to 15 min after.
    • An acoustic recording of children’s tears will be conducted in parallel with a microphone and dedicated software to study the properties of crying caused by the puncture. Continuous recording begins at least fifteen minutes before the procedure and is kept up to fifteen minutes after the invasive procedure. The child must be quiet. It will be placed in its cocoon to limit environmental stress
  • Frequency domain
    • Time Frame: From 15 min before the painful care to 15 min after.
    • It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
  • The time domain (SDNN, SDANN, pNN50).
    • Time Frame: From 15 min before the painful care to 15 min after.
    • It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
  • LF / HF ratio
    • Time Frame: From 15 min before the painful care to 15 min after.
    • It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
  • Electro acoustical characteristic of crying newborn : Frequency
    • Time Frame: From 15 min before the painful care to 15 min after.
    • An acoustic recording of children’s tears will be conducted in parallel with a microphone and dedicated software to study the properties of crying caused by the puncture. Continuous recording begins at least fifteen minutes before the procedure and is kept up to fifteen minutes after the invasive procedure. The child must be quiet. It will be placed in its cocoon to limit environmental stress
  • Electro acoustical characteristic of crying newborn : Frequency variations
    • Time Frame: From 15 min before the painful care to 15 min after.
    • An acoustic recording of children’s tears will be conducted in parallel with a microphone and dedicated software to study the properties of crying caused by the puncture. Continuous recording begins at least fifteen minutes before the procedure and is kept up to fifteen minutes after the invasive procedure. The child must be quiet. It will be placed in its cocoon to limit environmental stress

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy Newborn in maternity unit of the Saint-Etienne University Hospital (France), to receive venipuncture for blood tests or neonatal screening test – Establishing consent form signed by the holder of parental authority Exclusion Criteria:

  • Children suffering from a disease affecting the central nervous system. – Children treated with paracetamol oral solution (if cephalohematoma for example) or other analgesics (nalbuphine) or sedative, at the time of registration. – Newborns impregnated with a prepartum maternal analgesia.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 8 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hugues PATURAL, MD PhD, Principal Investigator, CHU de Saint-Etienne

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.