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

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

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).

Study Overview

• Status: Completed
• Conditions: Newborn; Neonatal Screening
• Intervention / Treatment: Drug: Glucose sucking; Drug: Water sucking; Other: No sucking

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • Chu de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Glucose sucking; Other Names: Glucose PROAMP 30%, Laboratoires AGUETTANT
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).	Drug: Water sucking; Other Names: Eau ppi, BRAUN
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.	Other: No sucking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High frequency normalized index (HFnu)	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.	From 15 min before the painful care to 15 min after.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low frequency (LF and LFnu),	It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.	From 15 min before the painful care to 15 min after.
Scale of hetero-assessment of pain (DAN)	The DAN scale is specific to acute pain of the newborn	15 minutes after the painful care
Electro acoustical characteristic of crying newborn : Duration	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	From 15 min before the painful care to 15 min after.
Frequency domain	It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.	From 15 min before the painful care to 15 min after.
The time domain (SDNN, SDANN, pNN50).	It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.	From 15 min before the painful care to 15 min after.
LF / HF ratio	It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.	From 15 min before the painful care to 15 min after.
Electro acoustical characteristic of crying newborn : Frequency	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	From 15 min before the painful care to 15 min after.
Electro acoustical characteristic of crying newborn : Frequency variations	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	From 15 min before the painful care to 15 min after.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hugues PATURAL, MD PhD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Autonomic Nervous System; Newborn; Neonatal Screening; non-nutritive sucking; sucrose administration; nociceptive action; Electro acoustical characteristics of crying
• Other Study ID Numbers: 1308143; 2013-005043-86 (EudraCT Number)

Plan for Individual participant data (IPD)

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