Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

Preterm Clinical Trial

— BABYDOUL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096822
• Other study ID #: K13802
• Secondary ID: PHRI 13335
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: February 23, 2016
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Facilitated Tucking
• Non Nutritive Sucking
• Pain Relief
• Premature Birth
• Preterm

Intervention

Behavioral:
• Facilitated tucking + non-nutritive sucking

Other:
• non-nutritive sucking

Locations

Country	Name	City	State
France	Hôpital A.Trousseau La roche Guyon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 sec before to 30 sec after heel-lance procedure	No
Secondary	DAN (Douleur Aigue Nouveau-né)	Behavioural measure of pain for premature infants; Indicators: Facial movement Members movement Vocal expression	15 sec before to 3 min after heel-lance procedure	No