Newborn Cortical Response to Pain and Non Pharmacological Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Other: Oral glucose solution + maternal holding; Other: Breastfeeding; Other: Oral glucose solution; Other: Oral expressed breastmilk

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 3 days (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Oral glucose solution + maternal holding; Infant will receive both the oral glucose solution and the contact with the mother
EXPERIMENTAL: Breastfeeding; Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure.	Other: Breastfeeding; Infants will be breastfed
ACTIVE_COMPARATOR: Oral glucose solution; Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table.	Other: Oral glucose solution; Infant will receive only oral glucose solution without contact with the mother
ACTIVE_COMPARATOR: Oral expressed breastmilk; Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table.	Other: Oral expressed breastmilk; Infant will receive only oral expressed breast milk without contact with the mother

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Fabio Barbone, Prof, Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy; Principal Investigator: Stefano Bembich, MSC, Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

Publications and helpful links

General Publications

• Bembich S, Cont G, Causin E, Paviotti G, Marzari P, Demarini S. Infant Analgesia With a Combination of Breast Milk, Glucose, or Maternal Holding. Pediatrics. 2018 Sep;142(3):e20173416. doi: 10.1542/peds.2017-3416.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2016
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pain; near-infrared spectroscopy; infant; non pharmacological analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Pharmaceutical Solutions
• Other Study ID Numbers: RC 50/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No