An interventional study of Water and Sucrose in Iron Deficiency, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in China. Open to participants aged 1 Day to 5 Days. Per ClinicalTrials.gov, last updated 2016-04-05.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable and Interventional
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.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's enrollment of 424 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Exclusion Criteria:
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.
Other: Water
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.
Other: Sucrose
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
Infant behavior (emotion regulation)
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
Time frame: up to 5 days old
Plan to share: Yes — On request after main findings are published.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)