Clinical trial NCT02374281: Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Newborn
Neonatal Screening
Keywords: Newborn
Neonatal Screening
Autonomic Nervous System
Pain
non-nutritive sucking
sucrose administration
nociceptive action
Electro acoustical characteristics of crying
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 180
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: High frequency normalized index (HFnu)
timeFrame: From 15 min before the painful care to 15 min after.
Secondary outcomes:
measure: Low frequency (LF and LFnu),
timeFrame: From 15 min before the painful care to 15 min after.
measure: Scale of hetero-assessment of pain (DAN)
timeFrame: 15 minutes after the painful care
measure: Electro acoustical characteristic of crying newborn : Duration
timeFrame: From 15 min before the painful care to 15 min after.
measure: Frequency domain
timeFrame: From 15 min before the painful care to 15 min after.
measure: The time domain (SDNN, SDANN, pNN50).
timeFrame: From 15 min before the painful care to 15 min after.
measure: LF / HF ratio
timeFrame: From 15 min before the painful care to 15 min after.
measure: Electro acoustical characteristic of crying newborn : Frequency
timeFrame: From 15 min before the painful care to 15 min after.
measure: Electro acoustical characteristic of crying newborn : Frequency variations
timeFrame: From 15 min before the painful care to 15 min after.
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Hugues PATURAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: