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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 3

Conditions: Newborn; Neonatal Screening

Treatments: Drug: Glucose sucking; Drug: Water sucking; Other: No sucking

Study type: Interventional

Funder types: Other

Identifiers

NCT02374281

1308143

2013-005043-86 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 180 patients

Sex: All

Ages: Under 8 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups, including a placebo group

Glucose sucking

Experimental group

Description:

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).

Treatment:

Drug: Glucose sucking

Water sucking

Active Comparator group

Description:

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).

Treatment:

Drug: Water sucking

No sucking

Placebo Comparator group

Description:

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

Treatment:

Other: No sucking