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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formula or Breast Milk | Active Comparator | Breast milk or formula prior to every painful procedure. |
|
| Multiple doses of sucrose | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiple doses of sucrose | Drug | unlimited number of doses par day- current status in our NICU |
|
| Measure | Description | Time Frame |
|---|---|---|
| neurodevelopmental outcomes | Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel | at 6 month corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| neurodevelopment | Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel | at 15 weeks corrected age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Morag, MD | Contact | +972526479996 | irismorag@gmail.com | |
| Tzipi Strauss, MD | Contact | +97235302215 | t.tzipi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Iris Morag, M.D | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12205254 | Result | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005526 | Food, Formulated |
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D019648 | Foods, Specialized |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Formula or breast milk | 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 |
|
|
| D000091642 | Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |
| D008892 | Milk |
| D001628 | Beverages |
| D003611 | Dairy Products |