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Non-pharmacological Analgesic Effects on Term Newborns

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ClinicalTrials.gov Identifier: NCT03421158
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Annette Nasr, Stanford University

Brief Summary:
The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.

Condition or disease Intervention/treatment Phase
Pain Breast Feeding Behavioral: breastfeeding Dietary Supplement: oral sucrose Behavioral: Skin-to-Skin contact Behavioral: Non-nutritive sucking Not Applicable

Detailed Description:

This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.

A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.

The average pain score from two research nurses were used for statistical analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance
Actual Study Start Date : November 7, 2014
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
No Intervention: Control
Newborns received no pain interventions during the procedure
Experimental: Breastfeeding
Newborns were breastfed during the procedure
Behavioral: breastfeeding
Newborns were breastfed during the procedure

Experimental: Oral Sucrose
Newborns were given oral sucrose during the procedure
Dietary Supplement: oral sucrose
Newborns were given oral sucrose during the procedure

Experimental: Skin to skin contact
Newborns were placed in direct contact with their mothers during the procedure
Behavioral: Skin-to-Skin contact
Newborns were placed in direct contact with their mothers during the procedure

Experimental: Non-nutritive sucking
Newborns were given a pacifier to suck on during the procedure
Behavioral: Non-nutritive sucking
newborns were given a pacifier to suck on during the procedure
Other Name: Pacifier




Primary Outcome Measures :
  1. Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions [ Time Frame: 12 month ]
    Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestational Age 38-40
  • 2.5-4.0kg
  • 24-48hours of age
  • Receiving heel lance procedure
  • Apgar>7 at birth
  • NPASS<3 at time of heel lance

Exclusion Criteria:

  • Prior heel lance procedure
  • birth trauma
  • forceps or vacuum delivery
  • maternal drug abuse during delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421158


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Jie Chang, BSN,MD Stanford University
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Responsible Party: Annette Nasr, Clinical Assistant Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03421158    
Other Study ID Numbers: 31216
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Annette Nasr, Stanford University:
neonates
Non-pharmacological