Trials / Completed
CompletedNCT02728141
Healthy Infant Development Project - Sucrose Component
Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 424 (actual)
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
- Sex
- All
- Age
- 1 Day – 5 Days
- Healthy volunteers
- Not accepted
Summary
Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. The opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. In order to compare response to pain and sucrose during heel stick in neonates with and without iron deficiency, healthy full-term Chinese infants were randomized to receive sucrose or water by syringe beforehand, in conjunction with heel stick for metabolic screening.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Water | 2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick |
| OTHER | Sucrose | 2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2016-04-05
- Last updated
- 2016-04-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02728141. Inclusion in this directory is not an endorsement.