Browsing by Author "Carlo, Waldemar A."

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Admission to the kangaroo mother care ward and maternal postpartum depression in Lusaka, Zambia: a randomised controlled trial study protocol
(2026-10-26) Manasyan, Albert; Lakhwani, Jyoti; Kapesa, Herbert; Menon, Anitha J.; Sharma, Anjali; Pry, Jake M.; Brown, Catherine; Tembo, Taniya; Carlo, Waldemar A.
Abstract Introduction: Postpartum depression (PPD) is a serious public health problem affecting 17% of women globally with higher rates (up to 40%) recorded in southern Africa. Admission to the neonatal intensive care unit (NICU) is a risk factor for PPD. The study aims to determine whether initiation of Kangaroo Mother Care (KMC) at the NICU followed by admission to the KMC Ward for continued support for more than 2 days before discharge home reduces maternal PPD and other maternal and infant adverse outcomes in low-resource settings. Methods and analysis: This study will enrol mother-infant dyads (n=612), fathers (up to n=612) and a purposive subset of mothers (n=24), fathers (n=24) and family members (n=24) who will complete in-depth interviews (IDIs). Mother-infant dyads will be recruited from the NICU at the Women and Newborn Hospital - University Teaching Hospitals in Lusaka, Zambia. Once deemed stable for admission to the KMC Ward as part of step-down care, mother-infant dyads will be randomised to either the control arm where they will remain at the KMC Ward ≤2 days per standard of care or the intervention arm where they will remain at the KMC Ward for >2 days. The primary outcome is maternal PPD at 6–8 weeks postnatal screened using the Edinburgh Postnatal Depression Scale (EPDS) screening tool. IDIs will explore the feasibility and barriers to practising KMC post-discharge from the perspective of the parents and other family members. Ethics and dissemination: The study was approved by the University of Zambia Biomedical Research Ethics Committee, the National Health Research Authority and the University of Alabama at Birmingham Institutional Review Board. A Data Safety Monitoring Board (DSMB) has been constituted. Dissemination will be via publications in peer-reviewed journals, conferences, social media and revision of national guidelines.
Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries.
(2023-May-23) Manasyan, Albert; Salas, Ariel A.; Nolen, Tracy; Chomba, Elwyn ; Mazariegos, Manolo; Antoinette, Kitoto T.; Saleem, Sarah; Naqvi, Farnaz; Hambidge, Michael K.; Goco, Norman; McClure, Elizabeth M.; Wallander, Jan L.; Biasini, Fred J.; Goldenberg, Robert L.; Bose, Carl L.; Koso-Thomas, Marion; Krebs, Nancy F.; Carlo, Waldemar A.
OBJECTIVE: The Bayley Scales of Infant Development (BSID) is the most used diagnostic tool to identify neurodevelopmental disorders in children under age 3 but is challenging to use in low-resource countries. The Ages and Stages Questionnaire (ASQ) is an easy-to-use, low-cost clinical tool completed by parents/caregivers that screens children for developmental delay. The objective was to determine the performance of ASQ as a screening tool for neurodevelopmental impairment when compared with BSID second edition (BSID-II) for the diagnosis of moderate-to-severe neurodevelopmental impairment among infants at 12 and 18 months of age in low-resource countries. METHODS: Study participants were recruited as part of the First Bites Complementary Feeding trial from the Democratic Republic of Congo, Zambia, Guatemala and Pakistan between October 2008 and January 2011. Study participants underwent neurodevelopmental assessment by trained personnel using the ASQ and BSID-II at 12 and 18 months of age. RESULTS: Data on both ASQ and BSID-II assessments of 1034 infants were analysed. Four of five ASQ domains had specificities greater than 90% for severe neurodevelopmental delay at 18 months of age. Sensitivities ranged from 23% to 62%. The correlations between ASQ communications subscale and BSID-II Mental Development Index (MDI) (r=0.38) and between ASQ gross motor subscale and BSID-II Psychomotor Development Index (PDI) (r=0.33) were the strongest correlations found. CONCLUSION: At 18 months, ASQ had high specificity but moderate-to-low sensitivity for BSID-II MDI and/or PDI <70. ASQ, when administered by trained healthcare workers, may be a useful screening tool to detect severe disability in infants from rural low-income to middle-income settings. TRIAL REGISTRATION NUMBER: NCT01084109.
Higher-volume breastmilk to improve growth among preterm infants in Zambia: A randomized clinical trial
(2026-05-05) Travers, Colm P; Salas, Ariel A; Jeffcoat, Seabrook; Lakhwani, Jyoti; Kapesa, Herbert; Nalwamba, Leukanji; Carlo, Waldemar A.; Manasyan, Albert
Abstract Objective: To test the hypothesis that among very preterm infants, higher-volume feeding versus usual-volume feeding with exclusive breastmilk improves growth at 40-weeks' postmenstrual age (PMA). Design/methods: We conducted a randomized controlled trial among preterm infants 28 0/7 to 31 6/7 weeks' gestation or weighing 1000-1999 g at birth admitted to the Kangaroo Mother Care Ward at the Women and Newborn Hospital, Lusaka, Zambia between June 2022 and February 2023. Study participants were randomized with a 1:1 parallel allocation to usual-volume breastmilk (140-180 ml/kg/day) or higher-volume breastmilk (200-240 ml/kg/day) achieved with additional breastmilk expression. Daily measurements of feeding volume were recorded until discharge. Following hospital discharge, study participants were assessed at 40-weeks' postmenstrual age for weight, length, mid-arm circumference, and head circumference. The primary outcome was growth velocity from enrolment to 40-weeks' postmenstrual age. Results: 190 preterm infants were enrolled. The mean±standard deviation (SD) number of days from enrollment to discharge was 9 ± 4 days. Recorded breastmilk volumes during hospitalization differed between groups (239 ±47 mL/kg/day in higher-volume versus 189±84 mL/kg/day in usual-volume; p < 0.001). There was no difference in growth velocity to 40 weeks' PMA between groups (mean±SD, higher-volume 14.1 ± 4.8 g/kg/day versus usual-volume 14.6 ± 5.4 g/kg/day; p = 0.51). The mid-arm circumference increased in the higher-volume group (10.9 ± 1.3 cm versus 10.5 ± 1.1 cm; p = 0.04) but other growth parameters did not differ at 40-weeks' postmenstrual age. Adverse outcomes did not differ. Conclusions: Higher-volume exclusive breastmilk feeding with breastmilk expression is feasible but did not improve growth velocity at 40-weeks' postmenstrual age in very preterm infants.
Postpartum depression among newly delivered mothers based on postnatal newborn care
(2025-11-28) Manasyan, Albert; Lakhwani, Jyoti; Kapesa, Herbert; Owuor, Kevin; Menon, Anitha J.; Bosomprah, Samuel; Nalwamba, Leukanji; Machona, Sylvia; Carlo, Waldemar A.
Abstract Background Postpartum depression (PPD) is a serious public health problem affecting ~ 17% of women globally, with higher rates recorded in southern Africa – ~40%. Admission to the neonatal intensive care unit (NICU) is a risk factor for PPD. Our primary hypothesis was that infant care in the Kangaroo Mother Care Ward (KMC) after NICU stay would be associated with a lower prevalence of maternal PPD. Methods We conducted a cross-sectional study among newly delivered mothers at the University Teaching Hospitals in Lusaka, Zambia, between June 2022 – May 2023. Mothers of infants discharged home from the Newborn Nursery (if NICU admission was not required), NICU (unwell newborns requiring NICU care), or NICU/KMC Ward (unwell newborns requiring NICU care followed by further monitoring at the KMC ward) were screened for PPD using the Edinburgh Postnatal Depression Scale (EPDS) screening tool at 6–8 weeks postnatally. Mothers who scored 11 + were categorized as having PPD. Poisson models were used to estimate prevalence ratios (PR) for screening positive for PPD. The primary outcome was PPD following KMC versus NICU discharge. Results We screened 1056 newly delivered women for PPD pooled from mother-infant pairs discharged from the newborn nursery (n = 352), NICU/KMC (n = 352), or NICU (n = 352). Overall, mothers’ average age was 27.5 years, 61.1% had secondary education, 59.2% were unemployed, and 11.2% were HIV-positive. The proportion of women who screened positive for maternal PPD among all three arms was 20.5% with anxiety reaching 50.5%. Mothers whose newborns were admitted to the NICU/KMC arm had a lower proportion of women who screened positive for PPD (21.3%) compared to those directly discharged home from the NICU (29.0%) (p < 0.001). The adjusted prevalence of PPD positivity rate was significantly higher in the NICU and KMC arms compared to the Newborn Nursery arm, RR = 2.44 (95% CI 1.61, 3.73) and RR = 1.94 (95% CI 1.04, 3.61), respectively. However, in the adjusted analysis, there was no significant difference in the PPD positivity rate between the KMC and the NICU arms. Conclusion Admission to the KMC ward following the NICU was not associated with a lower PPD prevalence among newly delivered mothers compared to direct NICU discharge.