Browsing by Author "Shahidullah, M."

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Duration of birth depression and neurodevelopmental outcomes after whole-body hypothermia for hypoxic ischemic encephalopathy in India, Sri Lanka and Bangladesh - an exploratory analysis of the HELIX trial
(Elsevier, 2024) Burgod, C.; Mazlan, M.; Pant, S.; Krishnan, V.; Garegrat, R.; Montaldo, P.; Muraleedharan, P.; Bandiya, P.; Kamalaratnam, C.N.; Chandramohan, R.; Manerkar, S.; Jahan, I.; Moni, S.C.; Shahidullah, M.; Rodrigo, R.; Sumanasena, S.; Sujatha, R.; Sathyanathan, B.P.; Joshi, A.R.; Pressler, R.R.; Bassett, P.; Shankaran, S.; Thayyil, S.
BACKGROUND: Effect of duration of birth depression on neurodevelopmental outcomes in low- and middle-income countries (LMICs) is not known. We examined the association of birth depression with brain injury, neurodevelopmental outcomes, and hypothermia after hypoxic ischemic encephalopathy (HIE) in south Asia. METHODS: We compared cerebral magnetic resonance (MR) at 2 weeks, and adverse outcomes (death or moderate or severe disability) at 18 months in 408 babies with moderate or severe HIE who had long birth depression (positive pressure ventilation (PPV) >10 min or Apgar score<6 at 10 min or cord pH < 7.0) and short birth depression (PPV for 5-10 min or Apgar score<6 at 5 min, but ≥6 at 10 min). FINDINGS: Long depression group (n = 201) had more severe HIE (32.8% versus 6.8%), mortality (47.5% versus 26.4%), death or disability at 18 months (62.2% versus 35.4%) (all p < 0.001), MR injury (Odds ratio; 95% CI) to basal ganglia (2.4 (1.3, 4.1); p = 0.003), posterior limb of internal capsule (2.3 (1.3, 4.3); p < 0.001) and white matter (1.7 (1.1, 2.7); p = 0.021), and lower thalamic N-acetylaspartate levels (7.69 ± 1.84 versus 8.29 ± 1.60); p = 0.031) than short depression group (n = 207). Three babies had no heartbeat at 5 min, of which 1 died and 2 survived with severe disability. No significant interaction between the duration of birth depression and whole-body hypothermia was seen for any of the MR biomarker or clinical outcomes. INTERPRETATION: Long birth depression was associated with more brain injury and adverse outcomes than short depression. Effect of hypothermia was not modified by duration of birth depression. FUNDING: National Institute for Health Research.
Early interventions for infants at risk for developmental impairment: The South Asian perspective
(All India Institute Of Medical Sciences, 2022) Vipulaguna, D.; Jahan, I.; Girish, M.; Chinnappa, G.D.; Gopalaswamy, S.; Shahidullah, M.; Sumanasena, S.P.
ABSTRACT: Majority of under-five children with developmental disabilities live in low- and middle-income countries (LMIC). A considerable proportion of disabilities results from perinatal adversities. The neonatal and infant mortality rates in India, Bangladesh, and Sri Lanka have improved over the last two decades, implying survival of infants at risk for developmental impairments. The need to thrive beyond survival is a well-recognized concept and it is imperative to establish high-risk infant follow-up (HRIF) programmes to capture these infants within the first 1000 d of life. Many challenges are present within the LMICs to identify infants at risk and to ensure early intervention (EI) during the window of optimal neural plasticity. However, it is essential to acknowledge the strengths within such systems to understand the impact of these programmes and packages on the activity and participation of these infants and their families. The International Classification of Functioning, Health and Disability for Children and Youth (ICF-CY) version is a holistic framework that will enable the families, clinicians, and policymakers to measure the impact of these interventions. Though all three countries have national policies to reach for high-risk infants, there is lack of published evidence on the successful implementation of such strategies. Therefore, it is timely to establish universally accessible, culturally appropriate and sustainable HRIF programmes. It is also recommended to measure the outcomes of such programmes based on the ICF-CY to understand the impact on the activity and participation of children in South Asia. KEYWORDS: Disability and health for children and youth; Early intervention; High-risk infant follow-up; International classification of functioning; South Asia.
Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial
(BioMed Central, 2017) Thayyil, S.; Oliveira, V.; Lally, P.J.; Swamy, R.; Bassett, P.; Chandrasekaran, M.; Mondkar, J.; Mangalabharathi, S.; Benkappa, N.; Seeralar, A.; Shahidullah, M.; Montaldo, P.; Herberg, J.; Manerkar, S.; Kumaraswami, K.; Kamalaratnam, C.; Prakash, V.; Chandramohan, R.; Bandya, P.; Mannan, M.A.; Rodrigo, R.; Nair, M.; Ramji, S.; Shankaran, S.; HELIX Trial group
BACKGROUND: Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-incomecountries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs. METHODS: We will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months. DISCUSSION: Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection.
Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh
(Elsevier Ltd., 2021) Thayyil, S.; Pant, S.; Montaldo, P.; Shukla, D.; Oliveira, V.; Ivain, P.; Bassett, P.; Swamy, R.; Mendoza, J.; Moreno-Morales, M.; Lally, P.J.; Benakappa, N.; Bandiya, P.; Shivarudhrappa, I.; Somanna, J.; Kantharajanna, U.B.; Rajvanshi, A.; Krishnappa, S.; Joby, P.K.; Jayaraman, K.; Chandramohan, R.; Kamalarathnam, C.N.; Sebastian, M.; Tamilselvam, I.A.; Rajendran, U.D.; Soundrarajan, R.; Kumar, V.; Sudarsanan, H.; Vadakepat, P.; Gopalan, K.; Sundaram, M.; Seeralar, A.; Vinayagam, P.; Sajjid, M.; Baburaj, M.; Murugan, K.D.; Sathyanathan, B.P.; Kumaran, E.S.; Mondkar, J.; Manerkar, S.; Joshi, A.R.; Dewang, K.; Bhisikar, S.M.; Kalamdani, P.; Bichkar, V.; Patra, S.; Jiwnani, K.; Shahidullah, M.; Moni, S.C.; Jahan, I.; Mannan, M.A.; Dey, S.K.; Nahar, M.N.; Islam, M.N.; Shabuj, K.H.; Rodrigo, R.; Sumanasena, S.; Abayabandara-Herath, T.; Chathurangika, G.K.; Wanigasinghe, J.; Sujatha, R.; Saraswathy, S.; Rahul, A.; Radha, S.J.; Sarojam, M.K.; Krishnan, V.; Nair, M.K.; Devadas, S.; Chandriah, S.; Venkateswaran, H.; Burgod, C.; Chandrasekaran, M.; Atreja, G.; Muraleedharan, P.; Herberg, J.A.; Chong, W.K.K.; Sebire, N.J.; Pressler, R.; Ramji, S.; Shankaran, S.; HELIX consortium
BACKGROUND: Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia. METHODS: We did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh. We enrolled infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home). Using a web-based randomisation system, we allocated infants into a group receiving whole body hypothermia (33·5°C) for 72 h using a servo-controlled cooling device, or to usual care (control group), within 6 h of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support, and access to 3 Tesla MRI scanners and spectroscopy. Masking of the intervention was not possible, but those involved in the magnetic resonance biomarker analysis and neurodevelopmental outcome assessments were masked to the allocation. The primary outcome was a combined endpoint of death or moderate or severe disability at 18-22 months, assessed by the Bayley Scales of Infant and Toddler Development (third edition) and a detailed neurological examination. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02387385. FINDINGS: We screened 2296 infants between Aug 15, 2015, and Feb 15, 2019, of whom 576 infants were eligible for inclusion. After exclusions, we recruited 408 eligible infants and we assigned 202 to the hypothermia group and 206 to the control group. Primary outcome data were available for 195 (97%) of the 202 infants in the hypothermia group and 199 (97%) of the 206 control group infants. 98 (50%) infants in the hypothermia group and 94 (47%) infants in the control group died or had a moderate or severe disability (risk ratio 1·06; 95% CI 0·87-1·30; p=0·55). 84 infants (42%) in the hypothermia group and 63 (31%; p=0·022) infants in the control group died, of whom 72 (36%) and 49 (24%; p=0·0087) died during neonatal hospitalisation. Five serious adverse events were reported: three in the hypothermia group (one hospital readmission relating to pneumonia, one septic arthritis, and one suspected venous thrombosis), and two in the control group (one related to desaturations during MRI and other because of endotracheal tube displacement during transport for MRI). No adverse events were considered causally related to the study intervention. INTERPRETATION: Therapeutic hypothermia did not reduce the combined outcome of death or disability at 18 months after neonatal encephalopathy in low-income and middle-income countries, but significantly increased death alone. Therapeutic hypothermia should not be offered as treatment for neonatal encephalopathy in low-income and middle-income countries, even when tertiary neonatal intensive care facilities are available. FUNDING: National Institute for Health Research, Garfield Weston Foundation, and Bill & Melinda Gates Foundation. TRANSLATIONS: For the Hindi, Malayalam, Telugu, Kannada, Singhalese, Tamil, Marathi and Bangla translations of the abstract see Supplementary Materials section.
Whole-body hypothermia, cerebral magnetic resonance biomarkers, and outcomes in neonates with moderate or severe hypoxic-ischemic encephalopathy born at tertiary care centers vs other facilities: A nested study within a randomized clinical trial
(American Medical Association, 2023) Thayyil, S.; Montaldo, P.; Krishnan, V.; Ivain, P.; Pant, S.; Lally, P.J.; Bandiya, P.; Benkappa, N.; Kamalaratnam, C.N.; Chandramohan, R.; Manerkar, S.; Mondkar, J.; Jahan, I.; Moni, S.C.; Shahidullah, M.; Rodrigo, R.; Sumanasena, S.; Sujatha, R.; Burgod, C.; Garegrat, R.; Mazlan, M.; Chettri, I.; Babu, S.P.; Joshi, A.R.; Swamy, R.; Chong, K.; Pressler, R.R.; Bassett, P.; Shankaran, S.
IMPORTANCE: The association between place of birth and hypothermic neuroprotection after hypoxic-ischemic encephalopathy (HIE) in low- and middle-income countries (LMICs) is unknown. OBJECTIVE: To ascertain the association between place of birth and the efficacy of whole-body hypothermia for protection against brain injury measured by magnetic resonance (MR) biomarkers among neonates born at a tertiary care center (inborn) or other facilities (outborn). DESIGN, SETTING, AND PARTICIPANTS: This nested cohort study within a randomized clinical trial involved neonates at 7 tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh between August 15, 2015, and February 15, 2019. A total of 408 neonates born at or after 36 weeks' gestation with moderate or severe HIE were randomized to receive whole-body hypothermia (reduction of rectal temperatures to between 33.0 °C and 34.0 °C; hypothermia group) for 72 hours or no whole-body hypothermia (rectal temperatures maintained between 36.0 °C and 37.0 °C; control group) within 6 hours of birth, with follow-up until September 27, 2020. EXPOSURE: 3T MR imaging, MR spectroscopy, and diffusion tensor imaging. MAIN OUTCOMES AND MEASURES: Thalamic N-acetyl aspartate (NAA) mmol/kg wet weight, thalamic lactate to NAA peak area ratios, brain injury scores, and white matter fractional anisotropy at 1 to 2 weeks and death or moderate or severe disability at 18 to 22 months. RESULTS: Among 408 neonates, the mean (SD) gestational age was 38.7 (1.3) weeks; 267 (65.4%) were male. A total of 123 neonates were inborn and 285 were outborn. Inborn neonates were smaller (mean [SD], 2.8 [0.5] kg vs 2.9 [0.4] kg; P = .02), more likely to have instrumental or cesarean deliveries (43.1% vs 24.7%; P = .01), and more likely to be intubated at birth (78.9% vs 29.1%; P = .001) than outborn neonates, although the rate of severe HIE was not different (23.6% vs 17.9%; P = .22). Magnetic resonance data from 267 neonates (80 inborn and 187 outborn) were analyzed. In the hypothermia vs control groups, the mean (SD) thalamic NAA levels were 8.04 (1.98) vs 8.31 (1.13) among inborn neonates (odds ratio [OR], -0.28; 95% CI, -1.62 to 1.07; P = .68) and 8.03 (1.89) vs 7.99 (1.72) among outborn neonates (OR, 0.05; 95% CI, -0.62 to 0.71; P = .89); the median (IQR) thalamic lactate to NAA peak area ratios were 0.13 (0.10-0.20) vs 0.12 (0.09-0.18) among inborn neonates (OR, 1.02; 95% CI, 0.96-1.08; P = .59) and 0.14 (0.11-0.20) vs 0.14 (0.10-0.17) among outborn neonates (OR, 1.03; 95% CI, 0.98-1.09; P = .18). There was no difference in brain injury scores or white matter fractional anisotropy between the hypothermia and control groups among inborn or outborn neonates. Whole-body hypothermia was not associated with reductions in death or disability, either among 123 inborn neonates (hypothermia vs control group: 34 neonates [58.6%] vs 34 [56.7%]; risk ratio, 1.03; 95% CI, 0.76-1.41), or 285 outborn neonates (hypothermia vs control group: 64 neonates [46.7%] vs 60 [43.2%]; risk ratio, 1.08; 95% CI, 0.83-1.41). CONCLUSIONS AND RELEVANCE: In this nested cohort study, whole-body hypothermia was not associated with reductions in brain injury after HIE among neonates in South Asia, irrespective of place of birth. These findings do not support the use of whole-body hypothermia for HIE among neonates in LMICs.