Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24% (no)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Iris Morag, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01742520
First received: November 18, 2012
Last updated: June 9, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Development
Drug: multiple doses of sucrose
Drug: Formula or breast milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • neurodevelopmental outcomes [ Time Frame: at 6 month corrected age ] [ Designated as safety issue: No ]
    Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel


Secondary Outcome Measures:
  • neurodevelopment [ Time Frame: at 15 weeks corrected age ] [ Designated as safety issue: No ]
    Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel


Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: sucrose 24%

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

  Eligibility

Ages Eligible for Study:   27 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742520

Contacts
Contact: Iris Morag, MD +972526479996 irismorag@gmail.com
Contact: Tzipi Strauss, MD +97235302215 t.tzipi@gmail.com

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Iris Morag, MD    +9725307170    irismorag@gmail.com   
Contact: Tzipora Strauss, MD    +9725302227      
Principal Investigator: Iris Morag, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Iris Morag, M.D Sheba Medical Center
  More Information

Publications:
Responsible Party: Dr. Iris Morag, Staff Neonatologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01742520     History of Changes
Other Study ID Numbers: SHEBA-12-9389-IM-CTIL
Study First Received: November 18, 2012
Last Updated: June 9, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Sheba Medical Center:
Preterm infant
pain
neurodevelopment

ClinicalTrials.gov processed this record on September 16, 2014