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Healthy Infant Development Project - Sucrose Component

NCT02728141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2016-04-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Water

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

OTHER

Sucrose

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Betsy Lozoff, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
1 Day
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02728141 on ClinicalTrials.gov