Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

Not Applicable

Completed

• Conditions: Non Nutritive Sucking; Facilitated Tucking; Preterm; Pain Relief
• Interventions: Behavioral: Facilitated tucking + non-nutritive sucking; Other: non-nutritive sucking

• Registration Number: NCT02096822
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Study Start: 2014-04
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facilitated tucking + non-nutritive sucking	Facilitated tucking + non-nutritive sucking	After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking.
non-nutritive sucking alone	non-nutritive sucking	After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital A.Trousseau La roche Guyon; 🇫🇷 Paris, France