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Healthy Infant Development Project - Sucrose Component

Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02728141
Enrollment
424
Registered
2016-04-05
Start date
2009-11-30
Completion date
2014-06-30
Last updated
2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Brief 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.

Interventions

OTHERWater

2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick

OTHERSucrose

2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 5 Days
Healthy volunteers
No

Inclusion criteria

* Full term healthy neonates participating in the Healthy Infant Development RCT (NCT00613717) in the folic acid/early postnatal placebo group and pre- and early postnatal iron-supplemented infants.

Exclusion criteria

* birth weight \< 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth

Design outcomes

Primary

MeasureTime frameDescription
Infant behavior (emotion regulation)up to 5 days oldInfant behavior observed included activity level, negative emotionality, alertness and soothability.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026