Newborn Cortical Response to Pain and Non Pharmacological Analgesia

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389789
• Other study ID #: RC 50/11
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: October 2018
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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)

Related Conditions & MeSH terms

• Analgesia

Intervention

Other:
• Oral glucose solution + maternal holding
Infant will receive both the oral glucose solution and the contact with the mother
• Breastfeeding
Infants will be breastfed
• Oral glucose solution
Infant will receive only oral glucose solution without contact with the mother
• Oral expressed breastmilk
Infant will receive only oral expressed breast milk without contact with the mother

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

References & Publications (1)

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). pii: e20173416. doi: 10.1542/peds.2017-3416. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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