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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Non Nutritive Sucking; Facilitated Tucking; Preterm; Pain Relief

Treatments: Behavioral: Facilitated tucking + non-nutritive sucking; Other: non-nutritive sucking

Study type: Interventional

Funder types: Other

Identifiers

NCT02096822

PHRI 13335 (Other Identifier)

K13802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

non-nutritive sucking alone

Active Comparator group

Description:

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

Treatment:

Other: non-nutritive sucking

Facilitated tucking + non-nutritive sucking

Experimental group

Description:

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

Treatment:

Behavioral: Facilitated tucking + non-nutritive sucking