Back to resultsNewborn Cortical Response to Pain and Non Pharmacological Analgesia
Primary Purpose
Analgesia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral glucose solution + maternal holding
Breastfeeding
Oral glucose solution
Oral expressed breastmilk
Sponsored by
About this trial
This is an interventional supportive care trial for Analgesia focused on measuring pain, infant, near-infrared spectroscopy, non pharmacological analgesia
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Oral glucose solution + maternal holding
Breastfeeding
Oral glucose solution
Oral expressed breastmilk
Arm Description
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.
Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure.
Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table.
Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table.
Outcomes
Primary Outcome Measures
Cortical oxy-haemoglobin increase
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03389789
First Posted
December 27, 2017
Last Updated
October 1, 2018
Sponsor
IRCCS Burlo Garofolo
1. Study Identification
Unique Protocol Identification Number
NCT03389789
Brief Title
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
Official Title
Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
pain, infant, near-infrared spectroscopy, non pharmacological analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral glucose solution + maternal holding
Arm Type
Experimental
Arm Description
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.
Arm Title
Breastfeeding
Arm Type
Experimental
Arm Description
Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure.
Arm Title
Oral glucose solution
Arm Type
Active Comparator
Arm Description
Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table.
Arm Title
Oral expressed breastmilk
Arm Type
Active Comparator
Arm Description
Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table.
Intervention Type
Other
Intervention Name(s)
Oral glucose solution + maternal holding
Intervention Description
Infant will receive both the oral glucose solution and the contact with the mother
Intervention Type
Other
Intervention Name(s)
Breastfeeding
Intervention Description
Infants will be breastfed
Intervention Type
Other
Intervention Name(s)
Oral glucose solution
Intervention Description
Infant will receive only oral glucose solution without contact with the mother
Intervention Type
Other
Intervention Name(s)
Oral expressed breastmilk
Intervention Description
Infant will receive only oral expressed breast milk without contact with the mother
Primary Outcome Measure Information:
Title
Cortical oxy-haemoglobin increase
Description
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Neonatal Infant Pain Scale (NIPS)
Description
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.
Time Frame
During the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Barbone, Prof
Organizational Affiliation
Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefano Bembich, MSC
Organizational Affiliation
Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30166366
Citation
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.
Results Reference
background
Learn more about this trial
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
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