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Healthy Infant Development Project - Sucrose Component

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

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date April 5, 2016
Study Start Date  ICMJE November 2009
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
Infant behavior (emotion regulation) [ Time Frame: up to 5 days old ]
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Infant Development Project - Sucrose Component
Official Title  ICMJE Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Iron Deficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Water
  • 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.
    Intervention: Other: Sucrose
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2016)
424
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728141
Other Study ID Numbers  ICMJE 1R01HD052069( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: On request after main findings are published.
Responsible Party Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Betsy Lozoff, MD University of Michigan
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP