Healthy Infant Development Project - Sucrose Component
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|ClinicalTrials.gov Identifier: NCT02728141|
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency||Other: Water Other: Sucrose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||424 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Placebo Comparator: Water
Newborn infants with ID numbers ending in odd numbers offered 2ml distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick.
2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
Active Comparator: Sucrose
Newborn infants with ID numbers ending in even numbers offered 2 ml 25% sucrose in distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick.
2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
- Infant behavior (emotion regulation) [ Time Frame: up to 5 days old ]Infant behavior observed included activity level, negative emotionality, alertness and soothability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728141
|Peking University First Hospital|
|Beijing, China, 100034|
|Principal Investigator:||Betsy Lozoff, MD||University of Michigan|