Newborn Cortical Response to Pain and Non Pharmacological Analgesia

NCT03389789 | Completed

• 1 other identifier: RC 50/11
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Analgesia

Keywords

pain; infant; near-infrared spectroscopy; non pharmacological analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neonatal Infant Pain Scale (NIPS)

  During the procedure

Study Arms (4)

Oral glucose solution + maternal holding

EXPERIMENTAL

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

Breastfeeding

EXPERIMENTAL

Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure.

Other: Breastfeeding

Oral glucose solution

ACTIVE COMPARATOR

Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table.

Other: Oral glucose solution

Oral expressed breastmilk

ACTIVE COMPARATOR

Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table.

Other: Oral expressed breastmilk

Interventions

Oral glucose solution + maternal holding OTHER

Infant will receive both the oral glucose solution and the contact with the mother

Oral glucose solution + maternal holding

Breastfeeding OTHER

Infants will be breastfed

Breastfeeding

Oral glucose solution OTHER

Infant will receive only oral glucose solution without contact with the mother

Oral glucose solution

Oral expressed breastmilk OTHER

Infant will receive only oral expressed breast milk without contact with the mother

Oral expressed breastmilk

Eligibility Criteria

• Age: 3 Days - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Full term healthy infants, needing a heel-prick for metabolic screening;
• Informed consent obtained from parents.

You may not qualify if:

• \- Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Related 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):e20173416. doi: 10.1542/peds.2017-3416.

  PMID: 30166366 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Lactation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Fabio Barbone, Prof

  Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

  STUDY CHAIR

• Stefano Bembich, MSC

  Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 4, 2018
• Study Start: November 2, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10