Facilitated Tucking, Non Nutritive Sucking, Preterm, Pain Relief
Conditions
Keywords
Facilitated tucking, Non nutritive sucking, Preterm, Pain relief
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.
Interventions
BEHAVIORALFacilitated tucking + non-nutritive sucking
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed