Newborn Cortical Response to Pain and Non Pharmacological Analgesia

NCT ID: NCT03389789

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-02
• Study Completion Date: 2017-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral glucose solution + maternal holding

Intervention Type: OTHER

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

Breastfeeding

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

Group Type: EXPERIMENTAL

Breastfeeding

Intervention Type: OTHER

Infants will be breastfed

Oral glucose solution

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

Group Type: ACTIVE_COMPARATOR

Oral glucose solution

Intervention Type: OTHER

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

Oral expressed breastmilk

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

Group Type: ACTIVE_COMPARATOR

Oral expressed breastmilk

Intervention Type: OTHER

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

Interventions

Oral glucose solution + maternal holding

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

Intervention Type: OTHER

Breastfeeding

Infants will be breastfed

Intervention Type: OTHER

Oral glucose solution

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

Intervention Type: OTHER

Oral expressed breastmilk

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio Barbone, Prof

Role: STUDY_CHAIR

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

Stefano Bembich, MSC

Role: PRINCIPAL_INVESTIGATOR

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

References

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.

Reference Type: BACKGROUND

PMID: 30166366 (View on PubMed)

Other Identifiers

RC 50/11

Identifier Type: -

Identifier Source: org_study_id