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Completed

NCT Number: NCT03389789

Newborn Cortical Response to Pain and Non Pharmacological Analgesia

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

3 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral glucose solution + maternal holding

Other

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

breastfeeding

Other

Infants will be breastfed

Oral glucose solution

Other

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

Oral expressed breastmilk

Other

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

Primary outcomes

  1. Cortical oxy-haemoglobin increase

    Time frame: During the procedure

    Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)

Secondary outcomes

  1. Neonatal Infant Pain Scale (NIPS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 4, 2018
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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