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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01742520

Enrollment

Registered

2012-12-05

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development

Keywords

Preterm infant, pain, neurodevelopment

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

Interventions

DRUGmultiple doses of sucrose

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

DRUGFormula 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

27 Weeks to 33 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactIris Morag, MD

irismorag@gmail.com+972526479996

Backup ContactTzipi Strauss, MD

t.tzipi@gmail.com+97235302215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026