Clinical Trials Directory

Trials / Completed

CompletedNCT02096822

Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
48 Hours
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALFacilitated tucking + non-nutritive sucking
OTHERnon-nutritive sucking

Timeline

Start date
2014-04-01
Primary completion
2015-08-01
Completion
2015-08-01
First posted
2014-03-26
Last updated
2016-02-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02096822. Inclusion in this directory is not an endorsement.