Healthy Infant Development Project - Sucrose Component

• ClinicalTrials.gov Identifier: NCT02728141
• Recruitment Status: Completed
• First Posted: April 5, 2016
• Last Update Posted: April 5, 2016
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Iron Deficiency	Other: Water; Other: Sucrose	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 424 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
• Study Start Date: November 2009
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 5 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China

Peking University First Hospital

Beijing, China, 100034

Sponsors and Collaborators

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

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• ClinicalTrials.gov Identifier: NCT02728141
• Other Study ID Numbers: 1R01HD052069 ( U.S. NIH Grant/Contract )
• First Posted: April 5, 2016
• Last Update Posted: April 5, 2016
• Last Verified: March 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: On request after main findings are published.

Additional relevant MeSH terms:

Anemia, Iron-Deficiency; Anemia, Hypochromic; Anemia; Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases