NCT00694174

Brief Summary

The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. The study will also determine whether the use of sucrose (sugar water) when given by mouth has any effect on pain related skin blood flow changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

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

Study Start

First participant enrolled

September 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
Last Updated

June 10, 2008

Status Verified

June 1, 2008

Enrollment Period

2 years

First QC Date

June 4, 2008

Last Update Submit

June 9, 2008

Conditions

Procedural Pain

Keywords

Procedural Pain in Newborn Infantsnewborn infantacute procedural painskin blood flow changessucrose analgesialaser doppler imagerneonatal infant pain scale

Outcome Measures

Primary Outcomes (1)

  • skin blood flow response (perfusion units, PU)

    immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)

Secondary Outcomes (6)

  • Heart rate

    10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance

  • Blood pressure

    10 minutes prior to heel lance, 5 minutes after heel lance

  • Respiratory rate

    10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance

  • axillary temperature

    10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance

  • oxygen saturation (SaO2)

    10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

2 ml sucrose 25% oral solution one time only dose by mouth

Drug: sucrose 24% oral solution

2

PLACEBO COMPARATOR

sterile water 2 ml one time only dose given by mouth prior to heel lance

Drug: sterile water

Interventions

sucrose 24% oral solutionDRUG

sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance

Also known as: Oral sucrose solution
1
sterile waterDRUG

sterile water 2 ml single dose to be administered orally one time prior to heel lance

Also known as: sterile water U.S.P.
2

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent from parent or legal guardian.
  • Term, newborn infant, between 1 and 7 days of age.
  • Appropriate for gestational age (weight 5th through 95th percentile).

You may not qualify if:

  • Small or large for gestational age (weight\<5th or \>95th percentile).
  • Physical or biochemical abnormalities.
  • History of maternal drug dependence.
  • Apgar score \<7 at 5 minutes.
  • Current use of analgesics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hutzel Women's University Hospital, The Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Related Publications (10)

  • Martin H, Lindblad B, Norman M. Endothelial function in newborn infants is related to folate levels and birth weight. Pediatrics. 2007 Jun;119(6):1152-8. doi: 10.1542/peds.2006-2706.

    PMID: 17545383BACKGROUND

  • Holland AJ, Martin HC, Cass DT. Laser Doppler imaging prediction of burn wound outcome in children. Burns. 2002 Feb;28(1):11-7. doi: 10.1016/s0305-4179(01)00064-x.

    PMID: 11834324BACKGROUND

  • Johnston CC, Stevens BJ. Experience in a neonatal intensive care unit affects pain response. Pediatrics. 1996 Nov;98(5):925-30.

    PMID: 8909487BACKGROUND

  • Gonsalves S, Mercer J. Physiological correlates of painful stimulation in preterm infants. Clin J Pain. 1993 Jun;9(2):88-93. doi: 10.1097/00002508-199306000-00003.

    PMID: 8358144BACKGROUND

  • Moustogiannis AN, Raju TN, Roohey T, McCulloch KM. Intravenous morphine attenuates pain induced changes in skin blood flow in newborn infants. Neurol Res. 1996 Oct;18(5):440-4. doi: 10.1080/01616412.1996.11740448.

    PMID: 8916058BACKGROUND

  • McCulloch KM, Ji SA, Raju TN. Skin blood flow changes during routine nursery procedures. Early Hum Dev. 1995 Apr 14;41(2):147-56. doi: 10.1016/0378-3782(95)01617-c.

    PMID: 7601018BACKGROUND

  • Bonamy AK, Martin H, Jorneskog G, Norman M. Lower skin capillary density, normal endothelial function and higher blood pressure in children born preterm. J Intern Med. 2007 Dec;262(6):635-42. doi: 10.1111/j.1365-2796.2007.01868.x. Epub 2007 Nov 7.

    PMID: 17986202BACKGROUND

  • Anand KJ, Johnston CC, Oberlander TF, Taddio A, Lehr VT, Walco GA. Analgesia and local anesthesia during invasive procedures in the neonate. Clin Ther. 2005 Jun;27(6):844-76. doi: 10.1016/j.clinthera.2005.06.018.

    PMID: 16117989BACKGROUND

  • Anand KJ, Aranda JV, Berde CB, Buckman S, Capparelli EV, Carlo W, Hummel P, Johnston CC, Lantos J, Tutag-Lehr V, Lynn AM, Maxwell LG, Oberlander TF, Raju TN, Soriano SG, Taddio A, Walco GA. Summary proceedings from the neonatal pain-control group. Pediatrics. 2006 Mar;117(3 Pt 2):S9-S22. doi: 10.1542/peds.2005-0620C.

    PMID: 16777824BACKGROUND

  • Tutag Lehr V, Cortez J, Grever W, Cepeda E, Thomas R, Aranda JV. Randomized placebo-controlled trial of sucrose analgesia on neonatal skin blood flow and pain response during heel lance. Clin J Pain. 2015 May;31(5):451-8. doi: 10.1097/AJP.0000000000000126.

    PMID: 24918475DERIVED

MeSH Terms

Conditions

Pain, Procedural

Interventions

SucroseSolutions

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsPharmaceutical Preparations

Study Officials

  • Victoria Tutag Lehr, Pharm.D.

    Children's Hospital of Michigan, The Detroit Medical Center, Wayne State University

    PRINCIPAL INVESTIGATOR

  • Josef Cortez, M.D.

    Hutzel Women's University Hospital, The Detroit Medical Center, Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 10, 2008

Study Start

September 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

June 10, 2008

Record last verified: 2008-06

Locations

US(1)