Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

NCT ID: NCT02096822

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-08-31

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.

Conditions

Facilitated Tucking; Non Nutritive Sucking; Preterm; Pain Relief

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

non-nutritive sucking alone

After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water.

Group Type: ACTIVE_COMPARATOR

non-nutritive sucking

Intervention Type: OTHER

Facilitated tucking + non-nutritive sucking

After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking.

Group Type: EXPERIMENTAL

Facilitated tucking + non-nutritive sucking

Intervention Type: BEHAVIORAL

Interventions

Facilitated tucking + non-nutritive sucking

Intervention Type: BEHAVIORAL

non-nutritive sucking

Intervention Type: OTHER

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

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Perroteau, Nurse

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique

Locations

Hôpital A.Trousseau La roche Guyon

Paris, , France

Countries

France

Other Identifiers

PHRI 13335

Identifier Type: OTHER

Identifier Source: secondary_id

K13802

Identifier Type: -

Identifier Source: org_study_id