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

Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01742520
• Other study ID #: SHEBA-12-9389-IM-CTIL
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2012
• Last updated: June 9, 2013
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2013
• Source: Sheba Medical Center
• Contact: Iris Morag, MD
• Phone: +972526479996
• Email: irismorag[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 27 Weeks to 33 Weeks

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Development

Intervention

Drug:
• multiple doses of sucrose
unlimited number of doses par day- current status in our NICU
• 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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. Pediatri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurodevelopmental outcomes	Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel	at 6 month corrected age	No
Secondary	neurodevelopment	Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel	at 15 weeks corrected age	No