Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%

June 9, 2013 updated by: Dr. Iris Morag, Sheba Medical Center

Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants

The purpose of this study is to determine the effect of sucrose 24% for pain prevention on preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful procedure,do not impair neurodevelopmental outcomes of preterm infants

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

preterm infants born at 27-33 weeks gestational age at Sheba Medical Center will be recruited for this study. Prior to invasive procedure infants will be treated with pacifier and swaddling as recommended by the American Academy of Pediatrics and Canadian Pediatric Society.

Group 1.Will be treated with Sucrose 24% 0.1-0.5ml on the anterior pat of the tongue 1-3 min prior to invasive procedure.

Group 2. Similar to group 1 but breast milk or formula will replace Sucrose.

Number of invasive procedures/day will be documented

General Movements by Prechtel will be used for developmental assessment at 2,4,6 weeks after birth and at 14-16 weeks corrected age

Griffiths developmental scales (GMDS) will be used at 40 weeks, 14-16 weeks corrected age, and 3-6 month corrected age

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Contact:
          • Tzipora Strauss, MD
          • Phone Number: +9725302227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • preterm infants born at SMC

Exclusion Criteria:

  • need for intubation
  • surgery
  • need for sedation
  • abnormal head ultrasound
  • genetic abnormalities
  • necrotizing enterocolitis
  • other painful conditions other than routine blood exams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Formula or Breast Milk
Breast milk or formula prior to every painful procedure.
Drug: Formula or breast milk
1-3 minutes prior to every painful procedure, breast milk or formula 0.5-1 ml will be given on the anterior part of the tongue
Other Names:
  • sucrose 24%
Active Comparator: Multiple doses of sucrose
Infants in this group will be treated with Sucrose 24% 0.5-1ml on the anterior pat of the tongue 1-3min prior to every invasive procedure
Drug: multiple doses of sucrose
unlimited number of doses par day- current status in our NICU
Other Names:
  • sucrose 24%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurodevelopmental outcomes
Time Frame: at 6 month corrected age
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
at 6 month corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurodevelopment
Time Frame: at 15 weeks corrected age
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
at 15 weeks corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

November 18, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 9, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-9389-IM-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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