Quality improvement initiative to improve the duration of Kangaroo Mother Care in tertiary care neonatal unit of South India.

BACKGROUND: India has the highest number of preterm births and maximum number of deaths due to prematurity. Chengalpattu Government Medical College had 11 593 deliveries annually in 2020, of which 2252 of neonates were low birth weight. 2016 Cochrane review concluded that Kangaroo Mother Care (KMC) reduces the morbidity and mortality in low birthweight infants. The average duration of KMC in our unit was around 4.6 hours/baby/day. OBJECTIVE: To improve the duration of KMC in stable low birthweight babies from short duration to continuous duration (>12 hours) over 8 weeks. METHODS: The implementation phase was conducted during January 2021 and February 2021. All babies with birth weight <2 kg and who were haemodynamically stable were enrolled. QI (Qualitympovement) team included staff nurses, nursing in charge, resident doctors and consultants. Potential barriers were listed using fishbone analysis. Various possible interventions were identified and a priority matrix was formed to decide the sequence of introduction of changes. The following measures were subsequently tested by multiple PDSA (Plan Do Study Act) cycles: ensuring the availability of KMC charts, combining KMC chart with individualised weight chart, documentation of KMC duration in case sheets, increasing number of KMC chairs, opening of mother-neonatal ICU (M-NICU), KMC slings for mothers, education videos in local language and rewards for mothers. OUTCOME INDICATOR: Duration of KMC, recorded by bedside nurses on daily basis. RESULTS: A total of 86 newborns were enrolled. At the end of 8 weeks, average duration of KMC increased to 16.6 hours/baby/day. The intervention which was most useful in increasing KMC duration was opening of M-NICU. We were able to sustain the improvement at the end of 6 months. CONCLUSION: Sequential measures taken as a part of QI initiative, helped to increase the average duration of KMC from 4.6 hours/day to 16.6 hours/day, without much additional resources.

Comparison of efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: study protocol of a randomized controlled non-inferiority trial.

BACKGROUND: Neonatal sepsis is a global public health problem. There is no consensus regarding the optimum duration of antibiotics for culture-proven neonatal sepsis. Published randomized controlled trials (RCTs) comparing shorter versus longer courses of antibiotics provide low-quality evidence with serious risk of bias. We hypothesized that among neonates with uncomplicated culture-proven sepsis, antibiotic duration of 7 days is not inferior to 14 days. METHODS: This is a multi-centric, parallel-group, stratified, block-randomized, active-controlled, non-inferiority trial with outcome assessment blinded. Stratification is by center and birth weight. Neonates weighing ≥1000 g at birth, with blood-culture-proven sepsis (barring Staphylococcus aureus and fungi), without conditions warranting > 14 days antibiotics, and who clinically remit, are enrolled in the RCT on day 7 of administration of sensitive antibiotics. They are randomly allocated to no further antibiotics (intervention arm: total 7 days) or 7 more days of the same antibiotics (control arm: total 14 days). Allocation is concealed by opaque, sealed envelopes. The primary outcome is "definite or probable relapse" within 21 days after antibiotic completion. Secondary outcomes include definite and probable relapses at various timepoints until day 35 post-randomization, secondary infections, and adverse events. The neonatologist adjudicating probable relapses and lab personnel are blinded. Three hundred fifty subjects will be recruited in each arm, assuming a non-inferiority margin of 7%, one-sided alpha error 5%, and power of 90%. Analysis will be per protocol and by intention-to-treat. An independent Data Safety Monitoring Board monitors adverse events and will perform one interim analysis when 50% of expected primary outcomes have occurred or 50% of subjects have completed follow-up, whichever is earlier. O'Brien-Fleming criteria will be used to stop for mid-term benefit and Pocock's to stop for mid-term harm. A priori subgroup analyses are planned by birth weight categories, gram-stain status of pathogens, and radiological pneumonia. DISCUSSION: This trial will provide evidence to guide practice regarding optimum duration of antibiotics for culture-proven neonatal bacterial sepsis. If a 7-day regime is proved to be non-inferior to a 14-day regime, it is likely to reduce hospital stay, costs, adverse effects of drugs, and nosocomial infections. TRIAL REGISTRATION: Clinical Trials Registry India CTRI/2017/09/009743 . Registered on 13 September 2017.