BABYDOUL: Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02096822

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Facilitated Tucking Non Nutritive Sucking Preterm Pain Relief	Behavioral: Facilitated tucking + non-nutritive sucking Other: non-nutritive sucking	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PIPP (Premature Infant Pain Profile) [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

Secondary Outcome Measures

DAN (Douleur Aigue Nouveau-né) [15 sec before to 3 min after heel-lance procedure]
Behavioural measure of pain for premature infants Indicators: Facial movement Members movement Vocal expression

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 48 Hours

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital A.Trousseau La roche Guyon	Paris		France	75012

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Anne Perroteau, Nurse, Assistance Publique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT02096822

Other Study ID Numbers:

K13802
PHRI 13335

First Posted:

Mar 26, 2014

Last Update Posted:

Feb 24, 2016

Last Verified:

Feb 1, 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris

Facilitated tucking

Non nutritive sucking

Preterm

Pain relief

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Feb 24, 2016