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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Formula or Breast Milk

Breast milk or formula prior to every painful procedure.

Group Type ACTIVE_COMPARATOR

Formula or breast milk

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

multiple doses of sucrose

Intervention Type DRUG

unlimited number of doses par day- current status in our NICU

Interventions

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multiple doses of sucrose

unlimited number of doses par day- current status in our NICU

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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sucrose 24% sucrose 24%

Eligibility Criteria

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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

Minimum Eligible Age

27 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes