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

February 23, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Hôpital A.Trousseau La roche Guyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-nutritive sucking alone
After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water.
Other: non-nutritive sucking
Experimental: Facilitated tucking + non-nutritive sucking
After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking.
Behavioral: Facilitated tucking + non-nutritive sucking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PIPP (Premature Infant Pain Profile)
Time Frame: 15 sec before to 30 sec after heel-lance procedure

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
15 sec before to 30 sec after heel-lance procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAN (Douleur Aigue Nouveau-né)
Time Frame: 15 sec before to 3 min after heel-lance procedure

Behavioural measure of pain for premature infants

Indicators:

Facial movement Members movement Vocal expression
15 sec before to 3 min after heel-lance procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Anne Perroteau, Nurse, Assistance Publique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K13802
  • PHRI 13335 (Other Identifier: Assistance publique)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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