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Healthy Infant Development Project - Sucrose Component

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status

Completed

Conditions

Iron Deficiency

Treatments

Other: Sucrose
Other: Water

Study type

Interventional

Funder types

NIH

Identifiers

NCT02728141
1R01HD052069

Details and patient eligibility

About

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.

Enrollment

424 patients

Sex

All

Ages

1 to 5 days old

Volunteers

No Healthy Volunteers

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

Trial design

424 participants in 2 patient groups, including a placebo group

Water
Placebo Comparator group
Description:
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.
Treatment:
Other: Water
Sucrose
Active Comparator group
Description:
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.
Treatment:
Other: Sucrose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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