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

NCT ID: NCT02374281

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Newborn; Neonatal Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Glucose sucking

Intervention Type: DRUG

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).

Group Type: ACTIVE_COMPARATOR

Water sucking

Intervention Type: DRUG

No sucking

The puncture made in the veins of the back of the hand, will be performed only once per patient per test.

Group Type: PLACEBO_COMPARATOR

No sucking

Intervention Type: OTHER

Interventions

Glucose sucking

Intervention Type: DRUG

Water sucking

Intervention Type: DRUG

No sucking

Intervention Type: OTHER

Other Intervention Names

Glucose PROAMP 30%, Laboratoires AGUETTANT; Eau ppi, BRAUN

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.

• Maximum Eligible Age: 8 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugues PATURAL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2013-005043-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1308143

Identifier Type: -

Identifier Source: org_study_id