Healthy Infant Development Project - Sucrose Component

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