Rajesh Pandey1,2, Neelakanta Kanike1,3, Mugahid Ibrahim1,4, Namita Swarup1, Dennis M Super1, Sharon Groh-Wargo1, Deepak Kumar5. 1. Department of Pediatrics, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA. 2. Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA. 3. Pediatrics, Deaconess Women's Hospital, Newburgh, IN, USA. 4. Department of Pediatrics, Cork University Maternity Hospital (CUMH), Cork, Ireland. 5. Department of Pediatrics, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA. dkumar@metrohealth.org.
Abstract
OBJECTIVE: To determine if lactose-free formula, compared to lactose-containing formula, decreases the cumulative morphine dose required to treat neonatal abstinence syndrome (NAS). STUDY DESIGN: In a double-blind clinical trial, we randomized 74 infants (36-42 weeks gestation) at risk for developing NAS due to in-utero exposure to opioids to receive eitherlactose-free (Similac Sensitive®) or lactose-containing (Similac Advance®) infant formula. The primary outcome measure was the cumulative dose of morphine used for the treatment of NAS during the first 14 days of life. RESULTS: Data on 69 (4 withdrew consent and 1 ineligible)/74 randomized infants were analyzed. Patient characteristics between the infant groups fed lactose-free (n = 34) vs. lactose-containing (n = 35) infant formula were similar except more common maternal heroin abuse in the latter group (p = 0.013). Cumulative morphine dose (20.7 ± 19.8 vs. 23 ± 23.5 mg, p = 0.61) between the two groups were similar. CONCLUSION:Lactose-free vs. lactose-containing infant formula did not change the outcomes of infants with NAS.
RCT Entities:
OBJECTIVE: To determine if lactose-free formula, compared to lactose-containing formula, decreases the cumulative morphine dose required to treat neonatal abstinence syndrome (NAS). STUDY DESIGN: In a double-blind clinical trial, we randomized 74 infants (36-42 weeks gestation) at risk for developing NAS due to in-utero exposure to opioids to receive either lactose-free (Similac Sensitive®) or lactose-containing (Similac Advance®) infant formula. The primary outcome measure was the cumulative dose of morphine used for the treatment of NAS during the first 14 days of life. RESULTS: Data on 69 (4 withdrew consent and 1 ineligible)/74 randomized infants were analyzed. Patient characteristics between the infant groups fed lactose-free (n = 34) vs. lactose-containing (n = 35) infant formula were similar except more common maternal heroin abuse in the latter group (p = 0.013). Cumulative morphine dose (20.7 ± 19.8 vs. 23 ± 23.5 mg, p = 0.61) between the two groups were similar. CONCLUSION:Lactose-free vs. lactose-containing infant formula did not change the outcomes of infants with NAS.
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