Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Breastfeeding | Experimental | Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure. |
|
| 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. |
|
| Oral expressed breastmilk | Active Comparator | Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral glucose solution + maternal holding | Other | Infant will receive both the oral glucose solution and the contact with the mother |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Infant Pain Scale (NIPS) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30166366 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| During the procedure |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |