Healthy Infant Development Project - Sucrose Component

March 30, 2016 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

424

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: Water
2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
Active Comparator: 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.
Other: Sucrose
2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant behavior (emotion regulation)
Time Frame: up to 5 days old
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
up to 5 days old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Betsy Lozoff, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HD052069 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On request after main findings are published.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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