Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking : A Controlled Randomized Single-center Study.
Overview
- Phase
- Phase 3
- Intervention
- Glucose sucking
- Conditions
- Newborn
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- High frequency normalized index (HFnu)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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).
Intervention: Glucose sucking
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).
Intervention: Water sucking
No sucking
The puncture made in the veins of the back of the hand, will be performed only once per patient per test.
Intervention: No sucking
Outcomes
Primary Outcomes
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 Outcomes
- Low frequency (LF and LFnu),(From 15 min before the painful care to 15 min after.)
- Scale of hetero-assessment of pain (DAN)(15 minutes after the painful care)
- The time domain (SDNN, SDANN, pNN50).(From 15 min before the painful care to 15 min after.)
- LF / HF ratio(From 15 min before the painful care to 15 min after.)
- Electro acoustical characteristic of crying newborn : Duration(From 15 min before the painful care to 15 min after.)
- Frequency domain(From 15 min before the painful care to 15 min after.)
- Electro acoustical characteristic of crying newborn : Frequency(From 15 min before the painful care to 15 min after.)
- Electro acoustical characteristic of crying newborn : Frequency variations(From 15 min before the painful care to 15 min after.)