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Completed

NCT Number: NCT02374281

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

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).

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Key information

Conditions

Newborn Neonatal Screening Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucose sucking

Drug

Other names: Glucose PROAMP 30%, Laboratoires AGUETTANT

Water sucking

Drug

Other names: Eau ppi, BRAUN

No sucking

Other

Primary outcomes

  1. 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

  1. Low frequency (LF and LFnu),

    Time frame: From 15 min before the painful care to 15 min after.

    It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.

  2. Scale of hetero-assessment of pain (DAN)

    Time frame: 15 minutes after the painful care

    The DAN scale is specific to acute pain of the newborn

  3. Electro acoustical characteristic of crying newborn : Duration

    Time frame: From 15 min before the painful care to 15 min after.

    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

  4. Frequency domain

    Time frame: From 15 min before the painful care to 15 min after.

    It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.

  5. The time domain (SDNN, SDANN, pNN50).

    Time frame: From 15 min before the painful care to 15 min after.

    It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.

  6. LF / HF ratio

    Time frame: From 15 min before the painful care to 15 min after.

    It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.

  7. Electro acoustical characteristic of crying newborn : Frequency

    Time frame: From 15 min before the painful care to 15 min after.

    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

  8. Electro acoustical characteristic of crying newborn : Frequency variations

    Time frame: From 15 min before the painful care to 15 min after.

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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.

Acronym: BBSUCROSE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2015
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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