Newborn Cortical Response to Pain and Non Pharmacological Analgesia

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Other: Oral glucose solution + maternal holding; Other: Breastfeeding; Other: Oral glucose solution; Other: Oral expressed breastmilk

• Registration Number: NCT03389789
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2018-01-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral glucose solution + maternal holding	Oral glucose solution + maternal holding	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.
Breastfeeding	Breastfeeding	Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure.
Oral glucose solution	Oral glucose solution	Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table.
Oral expressed breastmilk	Oral expressed breastmilk	Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Neonatal Infant Pain Scale (NIPS)	During the procedure	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.