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OpenTrials
Completed

NCT Number: NCT02096822

Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

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.

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Key information

Conditions

Facilitated Tucking Female Urogenital Diseases and Pregnancy Complications Non Nutritive Sucking Obstetric Labor Complications Obstetric Labor, Premature Pain Relief Pregnancy Complications Premature Birth Preterm Urogenital Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital A.Trousseau La roche Guyon

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facilitated tucking + non-nutritive sucking

Behavioral

non-nutritive sucking

Other

Primary outcomes

  1. PIPP (Premature Infant Pain Profile)

    Time frame: 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 outcomes

  1. DAN (Douleur Aigue Nouveau-né)

    Time frame: 15 sec before to 3 min after heel-lance procedure

    Behavioural measure of pain for premature infants

    Indicators:

    Facial movement Members movement Vocal expression

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: BABYDOUL

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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