Healthy Infant Development Project - 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.

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, 100034, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

Other

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

Sucrose

Other

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

Primary outcomes

Infant behavior (emotion regulation)

Time frame: up to 5 days old

Infant behavior observed included activity level, negative emotionality, alertness and soothability.

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Apr 5, 2016
Registry last updated: Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed