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

Primary Purpose

Development

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
multiple doses of sucrose
Formula or breast milk
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Development focused on measuring Preterm infant, pain, neurodevelopment

Eligibility Criteria

27 Weeks - 33 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Formula or Breast Milk

Multiple doses of sucrose

Arm Description

Breast milk or formula prior to every painful procedure.

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

Outcomes

Primary Outcome Measures

neurodevelopmental outcomes
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel

Secondary Outcome Measures

neurodevelopment
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel

Full Information

First Posted
November 18, 2012
Last Updated
June 9, 2013
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01742520
Brief Title
Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%
Official Title
Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development
Keywords
Preterm infant, pain, neurodevelopment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Formula or Breast Milk
Arm Type
Active Comparator
Arm Description
Breast milk or formula prior to every painful procedure.
Arm Title
Multiple doses of sucrose
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
multiple doses of sucrose
Other Intervention Name(s)
sucrose 24%
Intervention Description
unlimited number of doses par day- current status in our NICU
Intervention Type
Drug
Intervention Name(s)
Formula or breast milk
Other Intervention Name(s)
sucrose 24%
Intervention Description
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
Primary Outcome Measure Information:
Title
neurodevelopmental outcomes
Description
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
Time Frame
at 6 month corrected age
Secondary Outcome Measure Information:
Title
neurodevelopment
Description
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
Time Frame
at 15 weeks corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
27 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Morag, MD
Phone
+972526479996
Email
irismorag@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tzipi Strauss, MD
Phone
+97235302215
Email
t.tzipi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Morag, M.D
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Morag, MD
Phone
+9725307170
Email
irismorag@gmail.com
First Name & Middle Initial & Last Name & Degree
Tzipora Strauss, MD
Phone
+9725302227
First Name & Middle Initial & Last Name & Degree
Iris Morag, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12205254
Citation
Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
Results Reference
result

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

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