NCT02096822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

March 24, 2014

Last Update Submit

February 23, 2016

Conditions

Facilitated TuckingNon Nutritive SuckingPretermPain Relief

Keywords

Facilitated tuckingNon nutritive suckingPretermPain relief

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • DAN (Douleur Aigue Nouveau-né)

    15 sec before to 3 min after heel-lance procedure

Study Arms (2)

non-nutritive sucking alone

ACTIVE COMPARATOR

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

Other: non-nutritive sucking

Facilitated tucking + non-nutritive sucking

EXPERIMENTAL

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

Interventions

Facilitated tucking + non-nutritive suckingBEHAVIORAL
Facilitated tucking + non-nutritive sucking
non-nutritive suckingOTHER
non-nutritive sucking alone

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital A.Trousseau La roche Guyon

Paris, 75012, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Facilitated Tucking

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Infant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Anne Perroteau, Nurse

    Assistance Publique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

FR(1)