Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm, Facilitated Tucking, Non Nutritive Sucking, Pain Relief

Intervention / Treatment
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* Behavioral: Facilitated tucking + non-nutritive sucking
* Other: non-nutritive sucking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-nutritive sucking alone<br>After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water. | Other: non-nutritive sucking<br> <br> |
| Experimental: Facilitated tucking + non-nutritive sucking<br>After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking. | Behavioral: Facilitated tucking + non-nutritive sucking<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm, Facilitated tucking, Non nutritive sucking, Pain relief