Newborn Cortical Response to Pain and Non Pharmacological Analgesia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03389789

Enrollment

Registered

2018-01-04

Start date

2016-11-02

Completion date

2017-05-31

Last updated

2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

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

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.

Interventions

OTHEROral glucose solution + maternal holding

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

OTHERBreastfeeding

Infants will be breastfed

OTHEROral glucose solution

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

OTHEROral expressed breastmilk

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Days to 3 Days

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Cortical oxy-haemoglobin increase	During the procedure	Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)

Secondary

Measure	Time frame	Description
Neonatal Infant Pain Scale (NIPS)	During the procedure	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026