Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 424
- Locations
- 1
- Primary Endpoint
- Infant behavior (emotion regulation)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 5 Days (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Sucrose (Other)
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.
Intervention: Water (Other)
Outcomes
Primary Outcomes
Infant behavior (emotion regulation)
Time Frame: up to 5 days old
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
Secondary Outcomes
No secondary outcomes reported