Newborn Cortical Response to Pain and Non Pharmacological Analgesia

IRCCS Burlo Garofolo

Status: Completed

Conditions: Analgesia

Treatments: Other: Oral glucose solution; Other: Oral expressed breastmilk; Other: Oral glucose solution + maternal holding; Other: Breastfeeding

Study type: Interventional

Funder types: Other

Identifiers

NCT03389789

RC 50/11

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 3 to 3 days old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Oral glucose solution + maternal holding

Experimental group

Description:

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.

Treatment:

Other: Oral glucose solution + maternal holding

Breastfeeding

Experimental group

Description:

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

Treatment:

Other: Breastfeeding

Oral glucose solution

Active Comparator group

Description:

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

Treatment:

Other: Oral glucose solution

Oral expressed breastmilk

Active Comparator group

Description:

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

Treatment:

Other: Oral expressed breastmilk