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Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.
During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.
Pain experienced during the neonatal period is known to have long term effects on the baby.
The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glucose 25% | Experimental | 1 ml of glucose once |
|
| infant formula | Experimental | Materna RTF stage 1 |
|
| Water for Injection | Placebo Comparator | 1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose 25% | Drug | 1 ml glucose 25%, once |
| |
| Materna RTF Stage 1 |
| Measure | Description | Time Frame |
|---|---|---|
| less discomfort | the infant will experience less pain during examination | immediate, during examination (day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shay Barak, MD | Contact | 04-6652328 | sbarak@poria.health.gov.il | |
| Robyn Rubin, Coordinator | Contact | 04-6652328 | rrubin@poria.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Shay Barak, MD | The Baruch Pade Medical Center - Poriya | Principal Investigator |
| Amir Kushnir, MD | The Baruch Padeh Medical Center - Poria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU Department, The Baruch Padeh medical Center - Poriya | Tiberias | Israel |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D014867 | Water |
| D007267 | Injections |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Dietary Supplement |
1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination. |
|
|
| Water for Injection | Other | 1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination |
|
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |