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

Newborn Clinical Trial

— BBSUCROSE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374281
• Other study ID #: 1308143
• Secondary ID: 2013-005043-86
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2015
• Last updated: March 29, 2016
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neonatal Screening
• Newborn

Intervention

Drug:
• Glucose sucking

• Water sucking

Other:
• No sucking

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Scale of hetero-assessment of pain (DAN)	The DAN scale is specific to acute pain of the newborn	15 minutes after the painful care	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No