Healthy Infant Development Project - Sucrose Component

Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728141
• Other study ID #: 1R01HD052069
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: March 30, 2016
• Start date: November 2009
• Est. completion date: June 2014

Study information

• Verified date: March 2016
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

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

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant behavior (emotion regulation)	Infant behavior observed included activity level, negative emotionality, alertness and soothability.	up to 5 days old	No