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Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants (BABYDOUL)

Primary Purpose

Facilitated Tucking, Non Nutritive Sucking, Preterm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Facilitated tucking + non-nutritive sucking
non-nutritive sucking
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Facilitated Tucking focused on measuring Facilitated tucking, Non nutritive sucking, Preterm, Pain relief

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newborn from 28 weeks to 31 weeks +6 days GA.
  • Age from 0 to 48 hours of life.
  • Admission in intensive care unit or neonatal unit.
  • Need for more than 4 heel stick procedures per 24 hours.
  • One parents's consent

Exclusion Criteria:

  • Hemodynamic instability with initropic drug need.
  • Therapeutic Hypothermia in context of neonatal asphyxia.
  • Curarized child.
  • Neurologic anomaly of contact/tonus.
  • Lidocaine application during the 4 hours before the procedure

Sites / Locations

  • Hôpital A.Trousseau La roche Guyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

non-nutritive sucking alone

Facilitated tucking + non-nutritive sucking

Arm Description

After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water.

After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking.

Outcomes

Primary Outcome Measures

PIPP (Premature Infant Pain Profile)
Behavioural measure of pain for premature infants. Indicators: gestational age behavioural state before painful stimulus change in heart rate during painful stimulus change in oxygen saturation during painful stimulus brow bulge during painful stimulus eye squeeze during painful stimulus nasolabial furrow during painful stimulus

Secondary Outcome Measures

DAN (Douleur Aigue Nouveau-né)
Behavioural measure of pain for premature infants Indicators: Facial movement Members movement Vocal expression

Full Information

First Posted
March 24, 2014
Last Updated
February 23, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02096822
Brief Title
Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants
Acronym
BABYDOUL
Official Title
Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.
Detailed Description
After randomization, baby will receive heel stick procedure with either non-nutritive sucking and sterile water or non-nutritive sucking and sterile water combined with facilited tucking. The sequence will be filmed. Evaluation of PIPP and DAN will be done after viewing by 3 independent experts. Each child will receive only one procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facilitated Tucking, Non Nutritive Sucking, Preterm, Pain Relief
Keywords
Facilitated tucking, Non nutritive sucking, Preterm, Pain relief

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-nutritive sucking alone
Arm Type
Active Comparator
Arm Description
After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water.
Arm Title
Facilitated tucking + non-nutritive sucking
Arm Type
Experimental
Arm Description
After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated tucking + non-nutritive sucking
Intervention Type
Other
Intervention Name(s)
non-nutritive sucking
Primary Outcome Measure Information:
Title
PIPP (Premature Infant Pain Profile)
Description
Behavioural measure of pain for premature infants. Indicators: gestational age behavioural state before painful stimulus change in heart rate during painful stimulus change in oxygen saturation during painful stimulus brow bulge during painful stimulus eye squeeze during painful stimulus nasolabial furrow during painful stimulus
Time Frame
15 sec before to 30 sec after heel-lance procedure
Secondary Outcome Measure Information:
Title
DAN (Douleur Aigue Nouveau-né)
Description
Behavioural measure of pain for premature infants Indicators: Facial movement Members movement Vocal expression
Time Frame
15 sec before to 3 min after heel-lance procedure

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newborn from 28 weeks to 31 weeks +6 days GA. Age from 0 to 48 hours of life. Admission in intensive care unit or neonatal unit. Need for more than 4 heel stick procedures per 24 hours. One parents's consent Exclusion Criteria: Hemodynamic instability with initropic drug need. Therapeutic Hypothermia in context of neonatal asphyxia. Curarized child. Neurologic anomaly of contact/tonus. Lidocaine application during the 4 hours before the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Perroteau, Nurse
Organizational Affiliation
Assistance Publique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital A.Trousseau La roche Guyon
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

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