NCT02728141|CompletedDMC
Healthy Infant Development Project - Sucrose Component
Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
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Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
Sponsor study identifier
NIH
interventional
424
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 2014
Actual (reported)June 2014
Actual (reported)March 30, 2016
Actual (reported)April 5, 2016
Actual (reported)Infant behavior (emotion regulation)
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
up to 5 days old
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.
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 distilled water by syringe one time in the newborn'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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Peking University First Hospital
Beijing, 100034, China
Lumeng JC, Li X, He Y, Gearhardt A, Sturza J, Kaciroti NA, Li M, Asta K, Lozoff B. Greater analgesic effects of sucrose in the neonate predict greater weight gain to age 18 months. Appetite. 2020 Mar 1;146:104508. doi: 10.1016/j.appet.2019.104508. Epub 2019 Nov 4.
Betsy Lozoff, MD
University of Michigan
424 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2016
First Posted
April 5, 2016
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Vitamin C on Iron Absorption
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
April 5, 2016
Record last verified: 2016-03
On request after main findings are published.
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Source: ClinicalTrials.gov.
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