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

Sheba Medical Center

Status: Unknown

Conditions: Development

Treatments: Drug: Formula or breast milk; Drug: multiple doses of sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT01742520

SHEBA-12-9389-IM-CTIL

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 27 to 33 weeks old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Formula or Breast Milk

Active Comparator group

Description:

Breast milk or formula prior to every painful procedure.

Treatment:

Drug: Formula or breast milk

Multiple doses of sucrose

Active Comparator group

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

Treatment:

Drug: multiple doses of sucrose