Healthy Infant Development Project - Sucrose Component

NCT02728141 | Completed DMC

• 1 other identifier: 1R01HD052069
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Infant behavior (emotion regulation)

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

  up to 5 days old

Study Arms (2)

Water

PLACEBO COMPARATOR

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

Sucrose

ACTIVE COMPARATOR

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

Interventions

Water OTHER

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

Water

Sucrose OTHER

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

Sucrose

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• birth weight \< 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth

Sponsors & Collaborators

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

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (1)

• Lumeng JC, Li X, He Y, Gearhardt A, Sturza J, Kaciroti NA, Li M, Asta K, Lozoff B. Greater analgesic effects of sucrose in the neonate predict greater weight gain to age 18 months. Appetite. 2020 Mar 1;146:104508. doi: 10.1016/j.appet.2019.104508. Epub 2019 Nov 4.

  PMID: 31698014 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Water; Sucrose

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Betsy Lozoff, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 5, 2016
• Study Start: November 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 5, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)