Feasibility, Sustainability, and Effectiveness of the Implementation of "Facility-Team-Driven" Approach for Improving the Quality of Newborn Care in South India.

OBJECTIVES: The primary objective of the study was to assess the feasibility and sustainability of the implementation of the point of care quality improvement (POCQI) methodology for improving the quality of neonatal care at the level 2 special newborn care unit (SNCU). Additional objective was to evaluate the effectiveness of the quality improvement (QI) and preterm baby package training model. METHODS: This study was conducted in a level-II SNCU. The study period was divided into baseline; intervention and sustenance phases. The primary outcome i.e., feasibility was defined as completion of training for 80% or more health care professionals (HCPs) through workshops, their attendance in subsequent review meetings and, successful accomplishment of at least two plan-do-study-act (PDSA) cycles in each project. RESULTS: Of the total, 1217 neonates were enrolled during the 14 mo study period; 80 neonates in the baseline, 1019 in intervention and 118 in sustenance phases. Feasibility of training was achieved within a month of initiation of intervention phase; 22/24 (92%) nurses and 14/15 (93%) doctors attended the meetings. The outcomes of individual projects suggested an improvement in proportion of neonates being given exclusive breast milk on day 5 (22.8% to 78%); mean difference (95% CI) [55.2 (46.5 to 63.9)]. Neonates on any antibiotics declined, proportion of any enteral feeds on day one and duration of kangaroo mother care (KMC) increased. Proportion of neonates receiving intravenous fluids during phototherapy decreased. CONCLUSIONS: The present study demonstrates the feasibility, sustainability, and effectiveness of a facility-team-driven QI approach augmented with capacity building and post-training supportive supervision.

Periodic change of body position under phototherapy in term and preterm neonates with hyperbilirubinaemia.

BACKGROUND: Phototherapy is the mainstay of treatment of neonatal hyperbilirubinaemia. Periodic change in position of the neonate under phototherapy (from supine to prone or lateral positions) may improve the efficiency of phototherapy by hastening the access of phototherapy light to bilirubin deposited in different parts of the skin and subcutaneous tissue. OBJECTIVES: To evaluate the effects of periodic change of body position during phototherapy as compared to no prescribed change in body position, on serum total bilirubin level and duration of treatment in neonates with unconjugated hyperbilirubinaemia during the first 28 days of life. Secondary objectives of the review included evaluation of the efficacy of periodic change of body position on the need for or number of exchange transfusions, incidence of bilirubin-induced neurological damage (BIND), side effects of phototherapy, and sudden infant death syndrome (SIDS). SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to run comprehensive searches in the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 3) in the Cochrane Library and Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions on 5 March 2021. We also searched clinical trials databases and the reference lists of included studies and relevant reviews for randomised controlled trials (RCTs) and quasi-RCTs. SELECTION CRITERIA: We included RCTs and quasi-RCTs if they enrolled neonates (term and preterm) of either gender with unconjugated hyperbilirubinaemia requiring phototherapy and compared periodic change of the body position of the infant under phototherapy with no prescribed change in body position. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data, consulting with a third review author in the case of disagreement. We used standard Cochrane methodological procedures, including assessing the risk of bias of included studies. We used the GRADE approach to assess the certainty of evidence. Primary outcomes were the duration of phototherapy and rate of fall of serum bilirubin at 24 hours. Secondary outcomes included the need for exchange transfusion, number of exchange transfusions, incidence of BIND, and SIDS. MAIN RESULTS: We included five studies (343 neonates) with an overall high risk of bias in the review. The body position under phototherapy was changed every two hours or every two-and-a-half hours in two studies each, and every three hours in one study. Three of the five studies included healthy term neonates, whilst the other two studies also included preterm neonates (≥ 33 weeks' gestation); however, separate data about review outcomes in preterm neonates were not available. Periodic change in body position may lead to little or no difference in the duration of phototherapy (mean difference (MD) 1.71 hours, 95% confidence interval (CI) -3.17 to 6.59 hours; I² = 58%; 4 studies, 231 participants; low certainty evidence). Only one study reported the rate of fall of serum total bilirubin at 24 hours of starting the phototherapy. Periodic change in body position may lead to little or no difference in the rate of fall of serum total bilirubin at 24 hours (MD 0.02 mg/dL/h, 95% CI -0.02 to 0.06 mg/dL/h; 1 study, 100 participants; low certainty evidence). We downgraded the certainty of evidence to low due to risk of bias and imprecision. None of the included studies reported the need for or number of exchange transfusions, incidence of BIND, or SIDS. Lack of separate data precluded subgroup analysis. AUTHORS' CONCLUSIONS: The available evidence is insufficient to determine the effects of periodic change of body position compared with no prescribed change of body position under phototherapy. There is low certainty evidence that there may be little or no difference in the duration of phototherapy and rate of fall in bilirubin at 24 hours of starting phototherapy between periodic change in body position and no prescribed change of body position under phototherapy in term and preterm neonates. None of the included studies reported the effect of change of position on the need for or number of exchange transfusions, incidence of BIND, or SIDS. One study is awaiting classification and could not be included in the review. Further studies are needed to evaluate the effect of periodic change in body position under phototherapy, especially in neonates with haemolytic hyperbilirubinaemia and in very preterm neonates. The results of this systematic review apply mainly to neonates born at late-preterm or term gestation receiving phototherapy for non-haemolytic hyperbilirubinaemia.

Fortification of Breast Milk With Preterm Formula Powder vs Human Milk Fortifier in Preterm Neonates: A Randomized Noninferiority Trial.

Importance: Fortification of expressed breast milk (EBM) using commercially available human milk fortifiers (HMF) increases short-term weight and length in preterm very low-birth-weight (VLBW) neonates. However, the high cost and increased risk of feed intolerance limit their widespread use. Preterm formula powder fortification (PTF) might be a better alternative in resource-limited settings. Objective: To demonstrate that fortification of EBM by preterm formula powder is noninferior to fortification by HMF, in terms of short-term weight gain, in VLBW neonates. Design, Setting, and Participants: Open-label, noninferiority, randomized trial conducted from December 2017 to June 2019 at a level 3 neonatal unit in India. The trial enrolled preterm (born at or before 34 weeks of gestation) VLBW neonates receiving at least 100 mL/kg/d of feeds and consuming 75% of milk or more as EBM. Interventions: Neonates were randomly assigned to receive fortification by either PTF or HMF. Calcium, phosphorus, iron, vitamin D, and multivitamins were supplemented in PTF and only vitamin D in the HMF group to meet the recommended dietary allowances. Main Outcomes and Measures: The primary outcome was the weight gain until discharge from the hospital or 40 weeks' postmenstrual age, whichever was earlier; the prespecified noninferiority margin was 2 g/kg/d. Secondary outcomes included morbidities such as necrotizing enterocolitis, feed intolerance, and extrauterine growth restriction (<10th percentile on the Fenton chart at 40 weeks' postmenstrual age). Results: Of the 123 neonates enrolled, 60 and 63 were randomized to the PTF and HMF groups, respectively. The mean gestation (30.5 vs 29.9 weeks) and birth weight (1161 vs 1119 g) were comparable between the groups. There was no difference in the mean (SD) weight gain between the PTF and HMF groups (15.7 [3.9] vs 16.3 [4.0] g/kg/d; mean difference, -0.5 g/kg/d; 95% CI, -1.9 to 0.7). The lower bound of 95% CI did not cross the noninferiority margin. The incidence of feed intolerance was lower in the PTF group (1.4 vs 6.8 per 1000 patient-days; incidence rate ratio 0.19; 95% CI, 0.04 to 0.95), and fewer neonates required withholding of fortification for 24 hours or more (5% vs 22%; risk ratio, 0.22; 95% CI, 0.07 to 0.75). The incidence of necrotizing enterocolitis stage II or more (0 vs 5%) and extrauterine growth restriction (73% vs 81%) was comparable between the groups. Conclusions and Relevance: Fortification with preterm formula powder is not inferior to fortification with human milk fortifiers in preterm neonates. Given the possible reduction in feed intolerance and lower costs, preterm formula might be a better option for fortification, especially in resource-restricted settings. Trial Registration: Clinical Trial Registry, India Identifier: CTRI/2017/11/010593.

Effect of Umbilical Cord Milking vs Delayed Cord Clamping on Venous Hematocrit at 48 Hours in Late Preterm and Term Neonates: A Randomized Controlled Trial.

OBJECTIVE: To compare the effect of intact umbilical cord milking (MUC) and delayed cord clamping (DCC) on venous hematocrit at 48 (±6) hours in late preterm and term neonates (350/7- 426/7 wk). STUDY DESIGN: Randomized trial. SETTING AND PARTICIPANTS: All late preterm and term neonates (350/7 - 426/7 wk) neonates born in the labor room and maternity operation theatre of tertiary care unit were included. INTERVENTION: We randomly allocated enrolled neonates to MUC group (cord milked four times towards the baby while being attached to the placenta; n=72) or DCC group (cord clamped after 60 seconds; n=72). OUTCOME: Primary outcome was venous hematocrit at 48 (±6) hours of life. Additional outcomes were venous hematocrit at 48 (±6) hours in newborns delivered through lower segment caesarean section (LSCS), incidence of polycythemia requiring partial exchange transfusion, incidence of hyperbilirubinemia requiring phototherapy, and venous hematocrit and serum ferritin levels at 6 (±1) weeks of age. RESULTS: The mean (SD) hematocrit at 48 (±6) hours in the MUC group was higher than in DCC group [57.7 (4.3) vs. 55.9 (4.4); P=0.002]. Venous hematocrit at 6 (±1) weeks was higher in MUC than in DCC group [mean (SD), 37.7 (4.3) vs. 36 (3.4); mean difference 1.75 (95% CI 0.53 to 2.9); P=0.005]. Other parameters were similar in the two groups. CONCLUSION: MUC leads to a higher venous hematocrit at 48 (±6) hours in late preterm and term neonates when compared with DCC.

Delayed cord clamping in Rh-alloimmunised infants: a randomised controlled trial.

Despite advancement in medical care, Rh alloimmunisation remains a major cause of neonatal hyperbilirubinaemia, neuro-morbidity, and late-onset anaemia. Delayed cord clamping (DCC), a standard care now-a-days, is yet not performed in Rh-alloimmunised infants due to paucity of evidence. Hence, we randomised these infants of 28- to 41-week gestation to delayed cord clamping (N = 36) or early cord clamping (N = 34) groups. The primary outcome variable was venous packed cell volume (PCV) at 2 h of birth. The secondary outcomes were incidence of double volume exchange transfusion (DVET) and partial exchange transfusion (PET), duration of phototherapy (PT), functional echocardiography (parameters measured: superior vena cava flow, M-mode fractional shortening, left ventricular output, myocardial perfusion index, and inferior vena cava collapsibility) during hospital stay, and blood transfusion (BT) until 14 weeks of life. Neonates were managed as per unit protocol. The baseline characteristics of enrolled infants were comparable between the groups. The median (IQR) gestation and mean (SD) birth weight of enrolled infants were 35 (33-37) weeks and 2440 (542) g, respectively. The DCC group had a higher mean PCV at 2 h of life (48.4 ± 9.2 vs. 43.5 ± 8.7, mean difference 4.9% (95% CI 0.6-9.1), p = 0.03). However, incidence of DVET and PET, duration of PT, echocardiography parameters, and BT until 14 weeks of postnatal age were similar between the groups.Conclusion: DCC in Rh-alloimmunised infants improved PCV at 2 h of age without significant adverse effects.Trial registration: Clinical Trial Registry of India (CTRI), Ref/2016/11/012572 http://ctri.nic.in/Clinicaltrials, date of trial registration 19.12.2016, date of first patient enrolment 1 January 2017.What is Known:•Delayed cord clamping improves haematocrit, results in better haemodynamic stability, and decreases the need of transfusion in early infancy.•However, due to lack of evidence, potential risk of hyperbilirubinaemia, and exacerbation of anaemia (following delayed cord clamping), early cord clamping is the usual norm in Rh-alloimmunised infantsinfants.What is New:•Delayed cord clamping in Rh-alloimmunised infants improves haematocrit at 2 h of life without any increase in incidence of serious adverse effects.

Helping Babies Breathe, Second Edition: A Model for Strengthening Educational Programs to Increase Global Newborn Survival.

BACKGROUND: Helping Babies Breathe (HBB), a skills-based program in neonatal resuscitation for birth attendants in resource-limited settings, has been implemented in over 80 countries since 2010. Implementation studies of HBB incorporating low-dose high-frequency practice and quality improvement show substantial reductions in fresh stillbirth and first-day neonatal mortality. Revision of the program aimed to further augment provider and facilitator skills and address gaps in implementation with the goal of improving neonatal survival. METHODS: The Utstein Formula for Survival-Medical Science X Educational Efficiency X Local Implementation = Survival-provided a framework for the revisions. The 2015 Neonatal Resuscitation Consensus on Science and Treatment Recommendations by the International Liaison Committee on Resuscitation informed scientific updates, which were harmonized with the 2012 World Health Organization Basic Newborn Resuscitation Guidelines. Published literature and program reports, consensus guidelines on reprocessing equipment, systematic collection of suggestions from frontline users, and responses to a semistructured online questionnaire informed educational/implementation revisions. Links to maternal care were added. Draft materials underwent Delphi review and field testing in India and Sierra Leone. An Utstein-style meeting of stakeholders identified key actions for successful implementation. RESULTS: Scientific revisions included expectant management of infants with meconium-stained amniotic fluid, limitation of suctioning, and initiating and continuing effective ventilation until spontaneous respirations. Frontline users (N=102) suggested augmented simulation methods to build confidence and competence and additional guidance for facilitators on implementation. Users identified a need for sufficient practice during the workshop, systematized ongoing practice, and enough simulators for participants. Field trials refined approaches to self-reflection, feedback and debriefing, and quality improvement. Utstein meeting stakeholders validated the importance of quality improvement and use of data to improve outcomes. CONCLUSIONS: The second edition of HBB provides a newer paradigm of learning for providers that incorporates workshop practice, self-reflection, and feedback and debriefing to reinforce learning as well as the promotion of mentorship and development of facilitators, systems for low-dose high-frequency practice in facilities, and quality improvement related to neonatal resuscitation.

E-learning in newborn health - a paradigm shift for continuing professional development for doctors and nurses.

Neonatal mortality can be largely prevented by wide-scale coverage of components of essential newborn care and management of sick neonates in district-level healthcare facilities. A vital step in this direction is imparting the requisite knowledge and skill among healthcare providers. Medical education programs with their static curricula seldom adapt to the changing needs of neonatal healthcare providers in patient-centered, collaborative and remote delivery contexts. E-learning is emerging as the cutting edge tool towards refinement of knowledge, attitude and practices of physicians. Module-based e-learning courses can be blended with a skill learning contact period in partnering institutions thus saving resources and rapidly covering a wide geographical region with uniform standardized education. In this review, the authors discuss their experience with e-learning aimed at introducing and refining the understanding of sick newborn care among pre-service and in-service doctors who manage neonates.

Parenteral nutrition.

Nutritional insufficiency, leading to early growth deficits has long-lasting effects, including short stature and poor neurodevelopmental outcomes. Early enteral feeding is commonly limited by immaturity of gastrointestinal motor function in preterm neonates. To ensure that a stressed premature infant receives an adequate but not excessive amount of glucose, the amount of carbohydrate delivered in the form of dextrose is commonly initiated at the endogenous hepatic glucose production and utilization rate of 4 to 6 mg/kg/min; and 8 to 10 mg/kg/min in ELBW infants. The early provision of protein is critical to attain positive nitrogen balance and accretion as premature babies lose approximately 1% of their protein stores daily. Aminoacid can be used at concentrations of 3-3.5 g/kg/day and lipid at 3.5-4 g/kg/day as long as the fat intake remains less than 60% of nonprotein calories. Sodium, potassium, chloride, calcium, magnesium and phosphorus need to be provided in PN solution as per their daily needs. Hospital-acquired infection (HAI) is a major complication of PN. All efforts should be made to avoid it.