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

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
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
NCT ID
NCT02096822
First Posted
March 24, 2014
Last Updated
February 23, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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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