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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Newborn, Neonatal Screening

Intervention / Treatment
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* Drug: Glucose sucking
* Drug: Water sucking
* Other: No sucking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 8 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose sucking<br>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<br> <br> * Other names: Glucose PROAMP 30%, Laboratoires AGUETTANT;|
| Active Comparator: Water sucking<br>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<br> <br> * Other names: Eau ppi, BRAUN;|
| Placebo Comparator: No sucking<br>The puncture made in the veins of the back of the hand, will be performed only once per patient per test. | Other: No sucking<br> <br> |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, Neonatal Screening, Autonomic Nervous System, Pain, non-nutritive sucking, sucrose administration, nociceptive action, Electro acoustical characteristics of crying