Reactivity of the autonomic nervous system after a nociceptive stress in the newborn: Interest sucrose and non-nutritive sucking.
- Conditions
- MedDRA version: 18.0Level: LLTClassification code 10051566Term: Fasting blood glucoseSystem Organ Class: 100000004848Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2013-005043-86-FR
- Lead Sponsor
- CHU de Saint-Etienne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- age < 8 days
- hospitalised in lmotherhood unit of CHU of Saint-Etienne
- to receive a dextrostix right or left heel for analysis of blood glucose
- consent form signed by parents
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Children suffering from a disease of the central nervous system.
- Children treated with paracetamol oral solution or other analgesic (nalbuphine) or sedative at the time of registration.
- Newborns impregnated by maternal analgesia perpartum.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Describe the short-term responsiveness of the autonomic nervous system, during a nociceptive action in the newborn motherhood is different depending on whether it is preceded by non-nutritive sucking and / or administration of sucrose;Secondary Objective: Describe subjective perceptions (EDIN) and objective (ANI) pain during a nociceptive action in the newborn are different depending on whether this action is preceded by non-nutritive sucking and / or administration of sucrose;Primary end point(s): high frequency normalized index (HFnu) Variability RR short-term heart rate (HRV);Timepoint(s) of evaluation of this end point: at the dextrostix
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: at the dextrostix;Secondary end point(s): - Other indices of RR variability of heart rate (HRV) in the frequency domain (total power of the frequency spectrum (Ptot), low frequency (LF and LFnu), high frequency (HF) ratio LF / HF) and in the time domain (SDNN, SDANN, Pnn50).<br>- Index (ANI analgesia-nociception) from the MetroDoloris© monitor <br>- Scale hetero-assessment of pain: EDIN <br>- Features electro acoustic crying newborn: duration, frequency, frequency variations