NCT02859376

Brief Summary

The objective of this trial is to compare the analgesic effect of a single dose of oral sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular puncture) versus multiple doses of oral sucrose 24% administered two minutes before and during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

December 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

December 16, 2015

Last Update Submit

August 3, 2016

Conditions

Pain

Keywords

Preterm infantsPainSucrose

Outcome Measures

Primary Outcomes (1)

  • Change of analgesic efficacy Premature Infant Pain Profile (PIPP)

    The primary outcome of this study will be to evaluate the analgesic efficacy of sucrose 24% administration (single versus multiple doses) during blood sampling using Premature Infant Pain Profile (PIPP).

    2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture

Secondary Outcomes (25)

  • Change of analgesic efficacy Face, Legs, Activity, Cry, Consolability (FLACC)

    at 30 and 120 seconds after the skin puncture

  • Change of analgesic efficacy Visual Analogue Scale (VAS)

    at 30 and 120 seconds after the skin puncture

  • Change of analgesic efficacy Pain Monitor (skin electrical conductance)

    2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture

  • Pain evaluation during heel prick Vs vascular puncture PIPP

    Through study completion, an average of 1 year

  • Pain evaluation during heel prick Vs vascular puncture FLACC

    Through study completion, an average of 1 year

  • +20 more secondary outcomes

Study Arms (2)

sucrose24% 2 minutes before

ACTIVE COMPARATOR

sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE the skin breaking procedure

Dietary Supplement: sucrose 24%

sucrose24% 2minutes before and during

EXPERIMENTAL

sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE and DURING the skin breaking procedure

Dietary Supplement: sucrose 24%

Interventions

sucrose 24%DIETARY_SUPPLEMENT

Premature neonates undergoing blood samples through skin breaking procedures, meeting inclusion criteria, will be randomized as soon as the doctor decision to drown the blood is made, to either sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE the skin breaking procedure or sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE and DURING the skin breaking procedure, according to a computer generated randomization list.

sucrose24% 2 minutes beforesucrose24% 2minutes before and during

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm neonates with gestational age ranging from 23+ 0 to 36+ 6 weeks
  • undergoing blood sampling (either heel prick or vascular puncture)
  • age ≤ 40 week GA + 28 days at the time of blood sampling
  • parental written informed consent for participation in the study must be obtained

You may not qualify if:

  • Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH \< 7.0
  • Known genetic or chromosomal disorders
  • Myopathies and neuropathies interfering with pain assessment by pain scales
  • Sedation
  • Presence of central catheter allowing blood sampling without skin breaking
  • Other painful procedure less than 2 hours before blood sampling
  • Physiological instability (more than 6 episodes of bradycardia and/or apnea per day)
  • Maternal drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Padova

Padua, Padova, 35128, Italy

RECRUITING

Related Publications (6)

  • Cignacco EL, Sellam G, Stoffel L, Gerull R, Nelle M, Anand KJ, Engberg S. Oral sucrose and "facilitated tucking" for repeated pain relief in preterms: a randomized controlled trial. Pediatrics. 2012 Feb;129(2):299-308. doi: 10.1542/peds.2011-1879. Epub 2012 Jan 9.

    PMID: 22232305BACKGROUND

  • Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004950. doi: 10.1002/14651858.CD004950.pub3.

    PMID: 23235618BACKGROUND

  • Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.

    PMID: 22392168BACKGROUND

  • Yin T, Yang L, Lee TY, Li CC, Hua YM, Liaw JJ. Development of atraumatic heel-stick procedures by combined treatment with non-nutritive sucking, oral sucrose, and facilitated tucking: a randomised, controlled trial. Int J Nurs Stud. 2015 Aug;52(8):1288-99. doi: 10.1016/j.ijnurstu.2015.04.012. Epub 2015 Apr 23.

    PMID: 25939641BACKGROUND

  • Shah VS, Ohlsson A. Venepuncture versus heel lance for blood sampling in term neonates. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD001452. doi: 10.1002/14651858.CD001452.pub4.

    PMID: 21975734BACKGROUND

  • Stevens B, Yamada J, Lee GY, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD001069. doi: 10.1002/14651858.CD001069.pub4.

    PMID: 23440783BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paola Lago, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Mion, MD

CONTACT

+39 049 8213547tritrimi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 16, 2015

First Posted

August 9, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

IT(1)