There is growing evidence that less invasive surfactant administration (LISA) is a better alternative to the standard Intubate-surfactant-extubate (InSurE) procedure in spontaneously breathing ...preterm infants with RDS. The infant feeding tube is easily available and cost-effective in comparison to special catheters used for surfactant administration in various studies on LISA and cost-effective health care is the need of the hour for countries like ours which are Low and middle-income countries(LMICs).The present study was planned to compare the total duration of respiratory support in preterm babies between 26 to 34 weeks of gestation with RDS requiring surfactant therapy administered by LISA technique using an infant feeding tube or InSurE method. In this unblinded randomised controlled trial, 150 infants were allocated to LISA (n = 74) or InSurE group (n = 76). An 8F feeding tube was used for surfactant delivery in the LISA group. The primary outcome was the total duration of respiratory support required and secondary outcomes included the proportion of babies developing BPD, IVH, PDA, NEC, ROP, air leaks, CPAP failure, and those requiring a repeat dose of surfactant along with the duration of hospitalization, time to regain birth weight and Death. The baseline variables including birth weight and gestation age were similar in the two groups. Nearly 27% of the mothers did not receive any dose of antenatal steroids (ANS) while around 37% of the mothers received complete course of ANS. A high proportion of babies (57%) were delivered by cesarean section. Intrapharyngeal reflux was significantly more in babies who received surfactant with the LISA method in comparison to InSurE technique (32% v/s 3%, p < 0.001). There was no statistically significant difference in the primary outcome of the total duration of respiratory support in both groups with a median duration of 120 h, 95% CI (69-235), and p = 0.618. The need for invasive mechanical ventilation was significantly lower in the LISA group (p = 0.017) with RR (95% CI) 0.498 (0.259-0.958). The rate of CPAP failure was significantly lower in the LISA group (p = 0.005) with RR (95% CI) 0.55 (0.34-0.89). In this study, the total duration of hospital stay was reduced in the LISA group (19 days) compared to InSurE group (26 days), although the same was not statistically significant. LISA with an 8F feeding tube is feasible and an effective strategy for surfactant administration which resulted in a significant reduction in CPAP failure and the need for invasive mechanical ventilation.Trial registration: www.ctri.nic.in id CTRI/2020/05/025360. Trial was registered at CTRI on 26/05/2020. First case of trial was enrolled on 28/05/2020.
The COVID-19 pandemic has had a significant impact on the operation of donor human milk banks in various countries such as China, Italy and India. It is understandable that this impact on operations ...of donor human milk might hamper the capability of these milk banks to provide sufficient pasteurized donor milk to neonates who need it. Contrary to developed world, predominant donors in developing nations are mothers of hospitalised neonates who have a relatively long period of hospital stay. This longer maternal hospital stay enhances the feasibility of milk donation by providing mothers with access to breast pumps to express their milk. Any excess milk a mother expresses which is above the needs of their own infant can be voluntarily donated. This physical proximity of milk banks to donors may help continuation of human milk donation in developing nations during the pandemic. Nevertheless, protocols need to be implemented to i) ensure the microbiological quality of the milk collected and ii) consider steps to mitigate potential consequences related to the possibility of the donor being an asymptomatic carrier of COVID-19. We present the procedural modifications implemented at the Comprehensive Lactation Management Centre at Lady Hardinge Medical College in India to promote breastfeeding and human milk donation during the pandemic which comply with International and National guidelines. This commentary provides a perspective from a milk bank in India which might differ from the perspective of the international donor human milk banking societies.
WHO recommends donor milk as the next best choice if Mothers' own milk (MOM) is unavailable. At our milk bank, during the COVID 19 pandemic, we observed a steep decline in the collection of donor ...milk, while Pasteurised Donor human milk (PDHM) demand increased. This called for active intervention.
We employed the quasi-experimental quality improvement initiative. During September 2020 (baseline period) the team members identified modifiable bottlenecks and suggested interventions (using WhatsApp to increase follow up, telehealth and digital tools) which were implemented in October 2020 and the impact was evaluated till March 2021. The SMART aim was "to meet the demand (estimated as 15,000 ml/month) of donor milk for adjoining 80-bedded NICU". Process measures were; daily amount of donor milk collected, pasteurized donor milk disbursed to NICU, number of donors and frequency of donations. The balancing measure was that the collection of donor milk should not undermine the provision of freshly expressed MOM for babies.
Collection of donor milk increased by 180% from baseline during the Intervention phase. This was sustained throughout the sustenance phase (November 2020 and March 2021) with an average monthly collection of 16,500 ml. Strikingly, the increased follow-up of mothers with emphasis on MOM decreased the NICU's donor milk requirement from 13,300 ml (baseline) to 12,500 ml (intervention) to 8,300 ml (sustenance). Monitoring of daily MOM used in the NICU revealed a 32% surge from 20,000 ml (baseline) to 27,000 ml (intervention) sustained at 25,000 ml per month.
By improving the provisions of human milk banks, near-exclusive human milk feeding can be ensured even during the pandemic time.
Human milk (HM) is a highly evolutionary selected, complex biofluid, which provides tailored nutrition, immune system support and developmental cues that are unique to each maternal–infant dyad. In ...the absence of maternal milk, the World Health Organisation recommends vulnerable infants should be fed with screened donor HM (DHM) from a HM bank (HMB) ideally embedded in local or regional lactation support services. However, demand for HM products has arisen from an increasing awareness of the developmental and health impacts of the early introduction of formula and a lack of prioritisation into government‐funded and nonprofit milk banking and innovation. This survey of global nonprofit milk bank leaders aimed to outline the trends, commonalities and differences between nonprofit and for‐profit HM banking, examine strategies regarding the marketing and placement of products to hospital and public customers and outline the key social, ethical and human rights concerns. The survey captured information from 59 milk bank leaders in 30 countries from every populated continent. In total, five companies are currently trading HM products with several early‐stage private milk companies (PMCs). Products tended to be more expensive from PMC than HMB, milk providers were financially remunerated and lactation support for milk providers and recipients was not a core function of PMCs. Current regulatory frameworks for HM vary widely, with the majority of countries lacking any framework, and most others placing HM within food legislation, which does not include the support and care of milk donors and recipient prioritisation. Regulation as a Medical Product of Human Origin was only in place to prevent the sale of HM in four countries; export and import of HM was banned in two countries. This paper discusses the safety and ethical concerns raised by the commodification of HM and the opportunities policymakers have globally and country‐level to limit the potential for exploitation and the undermining of breastfeeding.
Global regulations for the provision of human milk (HM) vary or are entirely absent. Private companies supplying HM‐derived products are now available in numerous countries, with multiple differences in operational models compared to nonprofit HM banks. This paper discusses the potential safety and ethical concerns raised by the commodification of HM and the opportunities policymakers have globally and country‐level to limit the potential for exploitation and the undermining of breastfeeding.
Key messages
The number and scope of human milk (HM) profit‐making companies is increasing globally
Current regulatory frameworks for HM vary widely
Products offered by private milk companies (PMCs) are generally more expensive than from HM banks
Some PMCs are adopting marketing practices traditionally associated with breast milk substitute companies.
The health benefits of HM‐based fortifiers compared to bovine milk‐based fortifiers are unclear and may be marginal
The guidelines for surfactant therapy are largely based on studies done in developed coun1tries wherein the facility infrastructure, patient profile, and clinical practices are different from low- ...and middle-income countries (LMICs). Though SRT is widely practiced in developing countries, there exists variability in clinical practice. Our objective was to identify the factors which would predict the need of surfactant administration and develop a “clinical respiratory distress (RD) score” for surfactant administration in preterm neonates with respiratory distress. A prospective observational study was conducted in 153 preterm infants (26
0/7
to 34
6/7
weeks gestation) with respiratory distress who were managed with CPAP and/or surfactant where indicated. Gestation < 32 weeks, no antenatal corticosteroid (ANS), hypothermia at admission, Apgar score
<
3 at 1 minute, and Silverman score > 2 at 2 hours were found to be the significant factors in predicting surfactant requirement in multivariate regression analysis. A seven point scale was developed and categorized into two categories as < 4 and ≥ 4. The sensitivity, specificity, PPV, and NPV were 67%, 87%, 86%, and 68%, respectively, with a cutoff score ≥ 4. The positive likelihood ratio was 5.07 (95% CI 2.71–9.48), and negative likelihood ratio was 0.38 (95% CI 0.28–0.52). The observed rate of surfactant administration was found to be around 32% when the composite score was below four, and the rate increased to almost 86% when the composite score was ≥ 4. The predictive accuracy of the model was subsequently evaluated in a cohort of 56 preterm infants with respiratory distress.. Sensitivity, specificity and positive and negative predictive value during the validation phase were 97%, 73%, 85%, and 94%, respectively. With a composite score less than 4, the observed rate of surfactant administration was 6% (95% CI 1%–28%) as against the model predicted rate of 24%, while with composite score ≥ 4, the observed rate was 85% (95% CI 69%–94%) as against the model predicted rate of 90%.
Conclusion
: “Clinical RD score” is a simple score, which can be utilized for decision-making for early surfactant administration for preterm infants (26
0/7
to 34
6/7
weeks gestation) with respiratory distress.
Trial Registration
:
NCT03273764
What is Known:
•
Both CPAP and surfactant therapy are effective in management of preterm infants with RDS
.
•
The efficacy of surfactant replacement therapy is better when it is administered early in the course of disease
.
What is New:
•
Many of the known risk factors for RDS do not predict surfactant requirement
.
•
“Composite RD score” comprising of five independent predictors of surfactant requirement with a numeric cutoff may help decide which preterm neonates with respiratory distress need early surfactant administration in low- and middle-income countries
.
If maternal milk is unavailable, the World Health Organization recommends that the first alternative should be pasteurised donor human milk (DHM). Human milk banks (HMBs) screen and recruit milk ...donors, and DHM principally feeds very low birth weight babies, reducing the risk of complications and supporting maternal breastfeeding where used alongside optimal lactation support. The COVID‐19 pandemic has presented a range of challenges to HMBs worldwide. This study aimed to understand the impacts of the pandemic on HMB services and develop initial guidance regarding risk limitation. A Virtual Collaborative Network (VCN) comprising over 80 HMB leaders from 36 countries was formed in March 2020 and included academics and nongovernmental organisations. Individual milk banks, national networks and regional associations submitted data regarding the number of HMBs, volume of DHM produced and number of recipients in each global region. Estimates were calculated in the context of missing or incomplete data. Through open‐ended questioning, the experiences of milk banks from each country in the first 2 months of the pandemic were collected and major themes identified. According to data collected from 446 individual HMBs, more than 800,000 infants receive DHM worldwide each year. Seven pandemic‐related specific vulnerabilities to service provision were identified, including sufficient donors, prescreening disruption, DHM availability, logistics, communication, safe handling and contingency planning, which were highly context‐dependent. The VCN now plans a formal consensus approach to the optimal response of HMBs to new pathogens using crowdsourced data, enabling the benchmarking of future strategies to support DHM access and neonatal health in future emergencies.
Introduction: Elizabethkingia meningoseptica, a rare cause of sepsis and meningitis in neonates, often associated with a wide spectrum of clinical presentation. The objective of the study was to ...describe the clinical characteristics and outcome of neonates, who developed meningitis secondary to Elizabethkingia meningoseptica infection at a tertiary care Neonatal unit in India. Methods: This retrospective study was conducted in the neonatal unit of a tertiary care hospital in New Delhi. The clinical data including demographic data, clinical presentation, management, and outcome data were collected and analyzed. Results: During the study, 7 neonates with meningitis secondary to Elizabethkingia infection were identified. Majority of the neonates were preterm with a median gestational age of 31 (interquartile range: 29-33.5) weeks and a median birth weight of 1250 g (interquartile range: 1024-2065). The median age of onset of symptoms was 7 days. Lethargy (100%), apnea (85%), seizure (71%), and feeding difficulties (42%) were the common clinical presentations. Overall mortality during the period was 28.5%, and 60% of the survivor developed hydrocephalus. Isolated strains were resistant to the commonly used antibiotics (piperacillin-tazobactam, aminoglycosides, meropenem, and colistin) effective against Gram-negative organisms. The environmental screening was done but the potential source of infection could not be identified conclusively. Conclusion: Meningitis in neonates caused by Elizabethkingia represents a potentially life-threatening infection and is often associated with significant neurological impairment, especially in premature neonates. A prolonged duration of antibiotic therapy, longer hospital stay, and likelihood of adverse neurologic sequelae during the hospital stay and follow-up should be anticipated in such cases of meningitis.
ObjectivesTo determine the availability of continuous positive airway pressure (CPAP) and to provide an overview of its use in neonatal units in government hospitals across ...India.SettingCross-sectional cluster survey of a nationally representative sample of government hospitals from across India.Primary outcomesAvailability of CPAP in neonatal units.Secondary outcomesProportion of hospitals where infrastructure and processes to provide CPAP are available. Case fatality rates and complication rates of neonates treated with CPAP.ResultsAmong 661 of 694 government hospitals with neonatal units that provided information on availability of CPAP for neonatal care, 68.3% of medical college hospitals (MCH) and 36.6% of district hospitals (DH) used CPAP in neonates. Assessment of a representative sample of 142 hospitals (79 MCH and 63 DH) showed that air-oxygen blenders were available in 50.7% (95% CI 41.4% to 60.9%) and staff trained in the use of CPAP were present in 56.0% (45.8% to 65.8%) of hospitals. The nurse to patient ratio was 7.3 (6.4 to 8.5) in MCH and 6.6 (5.5 to 8.3) in DH. Clinical guidelines were available in 31.0% of hospitals (22.2% to 41.4%). Upper oxygen saturation limits of above 94% were used in 72% (59.8% to 81.6%) of MCH and 59.3% (44.6% to 72.5%) of DH. Respiratory circuits were reused in 53.8% (42.3% to 63.9%) of hospitals. Case fatality rate for neonates treated with CPAP was 21.4% (16.6% to 26.2%); complication rates were 0.7% (0.2% to 1.2%) for pneumothorax, 7.4% (0.9% to 13.9%) for retinopathy and 1.4% (0.7% to 2.1%) for bronchopulmonary dysplasia.ConclusionsCPAP is used in neonatal units across government hospitals in India. Neonates may be overexposed to oxygen as the means to detect and treat consequences of oxygen toxicity are insufficient. Neonates may also be exposed to nosocomial infections by reuse of disposables. Case fatality rates for neonates receiving CPAP are high. Complications might be under-reported. Support to infrastructure, training, guidelines implementation and staffing are needed to improve CPAP use.
Background
Small but stable low birth weight (LBW) neonates have needs similar to babies of normal weight with the need for extra support with feeding and temperature maintenance. Most health ...facilities admit such infants in the neonatal unit leading to the separation of the mother and baby. This separation exposes the infant to a potentially contaminated environment of the Neonatal intensive care unit (NICU) which is hazardous for stable infants (Invasive interventions, Intravenous alimentation, Infections) and also hampers the establishment of breastfeeding. This study evaluated short-term outcomes of stable neonates weighing 1500-2000 grams at birth cared for in the mother-baby unit in the same room. as their mothers as per the ‘Zero-separation Policy’.
Methods
Neonates born vaginally with a birth weight of 1500-2000 grams with stable vitals were moved with their mothers to a 12-bed ’’mother-baby unit (MBU)“. Mothers were counseled regarding breastfeeding (BF), Kangaroo mother care (KMC), maintenance of general hygiene, and identification of danger signs. Infants developing moderate to severe hypothermia, hypoglycemia, feed intolerance (FI), jaundice nearing exchange transfusion range, respiratory difficulty, sepsis, seizures, or apnea, were moved to a neonatal unit for further management.
Results
Over 3 years, 489 neonates with a mean (± SD) birth weight of 1738 ± 102 grams and median gestation of 34 weeks (range: 32-41 weeks) were cared for with their mothers at the MBU. Seventy percent of infants exclusively received their mother’s own milk on day 1, which increased to more than 95% from day 4 onwards. Similarly, two-thirds of the mothers provided KMC for at least 5-8 hours on day 1, increasing to 85% by day 5. Neonatal hyperbilirubinemia requiring treatment was the most common morbidity (28.8%), most of which was managed at the bedside, followed by hypoglycemia (4.7%). Only 8% of neonates (n= 39/489) required transfer to the neonatal unit, mostly for hypoglycemia and hyperbilirubinemia. No baby developed hypothermia, apnea, FI, seizures, or hemodynamic instability. Successful discharge to home was accomplished in all neonates with no mortality.
Conclusions
Zero-separation policy is feasible in clinically stable low-weight or small neonates (of 1500-2000 grams) who can be nurtured with their mothers right from birth, ensuring timely feeding, KMC, and good hygienic practices.
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