Neonatal Screening, Newborn
Conditions
Keywords
Newborn, Neonatal Screening, Autonomic Nervous System, Pain, non-nutritive sucking, sucrose administration, nociceptive action, Electro acoustical characteristics of crying
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.
Interventions
DRUGGlucose sucking
DRUGWater sucking
OTHERNo sucking
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High frequency normalized index (HFnu) | 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
| Measure | Time frame | Description |
|---|---|---|
| Scale of hetero-assessment of pain (DAN) | 15 minutes after the painful care | The DAN scale is specific to acute pain of the newborn |
| Electro acoustical characteristic of crying newborn : Duration | 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 |
| Frequency domain | 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. |
| Low frequency (LF and LFnu), | 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. |
| LF / HF ratio | 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. |
| Electro acoustical characteristic of crying newborn : Frequency | 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 |
| Electro acoustical characteristic of crying newborn : Frequency variations | 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 |
| The time domain (SDNN, SDANN, pNN50). | 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. |
Countries
France
Outcome results
None listed