Newborn Cortical Response to Pain and Non Pharmacological Analgesia

Study Overview
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Brief Summary
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Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.

Official Title
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Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia

Conditions
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Analgesia

Intervention / Treatment
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* Other: Oral glucose solution + maternal holding
* Other: Breastfeeding
* Other: Oral glucose solution
* Other: Oral expressed breastmilk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term healthy infants, needing a heel-prick for metabolic screening; Informed consent obtained from parents. Exclusion Criteria: - Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral glucose solution + maternal holding<br>Infants will receive 2 mL of oral glucose solution two minutes before the heel-prick and will be held in the mothers' lap (maternal relationship) throughout the painful procedure. | Other: Oral glucose solution + maternal holding<br>* Infant will receive both the oral glucose solution and the contact with the mother<br>|
| Experimental: Breastfeeding<br>Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure. | Other: Breastfeeding<br>* Infants will be breastfed<br>|
| Active Comparator: Oral glucose solution<br>Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table. | Other: Oral glucose solution<br>* Infant will receive only oral glucose solution without contact with the mother<br>|
| Active Comparator: Oral expressed breastmilk<br>Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table. | Other: Oral expressed breastmilk<br>* Infant will receive only oral expressed breast milk without contact with the mother<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical oxy-haemoglobin increase | Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2) | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Infant Pain Scale (NIPS) | The NIPS assesses 5 behavioral factors (facial expression, cry, arms, legs, and state of arousal) and one physiological factor (breathing patterns), each of which contains two items that are assigned scores of 0 or 1 (except for the crying factor, which comprises three items and is scored on a scale of 0 to 2). The scale yields a total score ranging from 0 to 7, where scores more than 3 are indicative of pain. | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, infant, near-infrared spectroscopy, non pharmacological analgesia