Protocol for the Birth Asphyxia in African Newborns (Baby BRAiN) Study: a Neonatal Encephalopathy Feasibility Cohort Study.

BACKGROUND: Neonatal encephalopathy (NE) is a leading cause of child mortality worldwide and contributes substantially to stillbirths and long-term disability. Ninety-nine percent of deaths from NE occur in low-and-middle-income countries (LMICs). Whilst therapeutic hypothermia significantly improves outcomes in high-income countries, its safety and effectiveness in diverse LMIC contexts remains debated. Important differences in the aetiology, nature and timing of neonatal brain injury likely influence the effectiveness of postnatal interventions, including therapeutic hypothermia. METHODS: This is a prospective pilot feasibility cohort study of neonates with NE conducted at Kawempe National Referral Hospital, Kampala, Uganda. Neurological investigations include continuous video electroencephalography (EEG) (days 1-4), serial cranial ultrasound imaging, and neonatal brain Magnetic Resonance Imaging and Spectroscopy (MRI/ MRS) (day 10-14). Neurodevelopmental follow-up will be continued to 18-24 months of age including Prechtl's Assessment of General Movements, Bayley Scales of Infant Development, and a formal scored neurological examination. The primary outcome will be death and moderate-severe neurodevelopmental impairment at 18-24 months. Findings will be used to inform explorative science and larger trials, aiming to develop urgently needed neuroprotective and neurorestorative interventions for NE applicable for use in diverse settings. DISCUSSION: The primary aims of the study are to assess the feasibility of establishing a facility-based cohort of children with NE in Uganda, to enhance our understanding of NE in a low-resource sub-Saharan African setting and provide infrastructure to conduct high-quality research on neuroprotective/ neurorestorative strategies to reduce death and disability from NE. Specific objectives are to establish a NE cohort, in order to 1) investigate the clinical course, aetiology, nature and timing of perinatal brain injury; 2) describe electrographic activity and quantify seizure burden and the relationship with adverse outcomes, and; 3) develop capacity for neonatal brain MRI/S and examine associations with early neurodevelopmental outcomes.

Dextrose boluses versus burette dextrose infusions in prevention of hypoglycemia among preterms admitted at Mulago Hospital: an open label randomized clinical trial.

BACKGROUND: Hypoglycemia is a major cause of morbidity and mortality among preterm infants and its management remains a challenge in resource limited settings. Use of dextrose infusion by the recommended infusion pumps is not feasible in our environment due to their high costs and yet the current use of mini dextrose boluses with syringes as adapted at Mulago national referral and tertiary teaching hospital has unknown efficacy in prevention of hypoglycemia. OBJECTIVE: We determined the efficacy of dextrose infusions by burettes versus two hourly dextrose boluses in prevention of hypoglycemia among preterms admitted in the first 72 hours at Special Care Unit, Mulago Hospital. METHODS: One hundred and forty preterms aged 0 to 24 hours of life were randomized to receive 10% IV dextrose either as mini boluses or by infusion using burettes in an open label clinical trial. Blood glucose was measured at 0, two hourly for next 6 hours, 6 hourly for next 12 hours and thereafter 12 hourly until end of 72 hours following admission. Primary end point was incidence of hypoglycemia (random blood sugar (RBS) < 2.6 mmol/l) which was expressed as relative risk (RR). Efficacy of the dextrose infusion was computed using 1-RR. RESULTS: From February 2012 to April 2012, 68 preterms in the bolus arm and 72 in the infusion arm were studied. Hypoglycemia was detected in 34% (48/140). The incidence of hypoglycemia in the bolus arm was 59% (40/68) compared to 11% (8/72) in the infusion arm (RR; 0.19, 95% CI; 0.09-0.37). Efficacy (1-RR) of infusion by burettes versus boluses in prevention of hypoglycemia among preterms was 0.81 (95% CI; 0.63-0.90). CONCLUSION: Continuous 10% dextrose infusion by burettes reduced the incidence of hypoglycemia by 81% in the first 72 hours of admission compared to two hourly 10% mini dextrose boluses among preterms admitted at Special Care Unit, Mulago Hospital. (ClinicalTrials.gov Identifier: NCT01688674).

Upper GI bleeding among neonates admitted to Mulago Hospital, Kampala, Uganda: a prospective cohort study.

BACKGROUND: The World Health Organization (WHO) reports estimate that 85% of newborn deaths are due to infections, prematurity and fetal distress. These conditions are risk factors for upper GI bleeding (UGIB) in sick neonates. UGIB is associated with poor neonatal outcomes such as prolonged hospitalisation and poor weight gain. The magnitude of UGIB and its contribution to neonatal morbidity has not been described in most low income countries. OBJECTIVE: To determine the occurrence and factors associated with UGIB among neonates admitted to the Special Care Unit (SCU) of Mulago Hospital. METHODS: This was a prospective single cohort study where neonates admitted within 24 hours of birth were consecutively enrolled and followed up for seven days. Gastric aspirates from the neonates were examined daily over a period of 7 days using Guaiac and Apt tests for evidence of UGIB. Data on occurrence of UGIB has been presented as proportions and Odds Ratios for associated factors. RESULTS: Out of 191 neonates, 44 (23 %) developed UGIB. Factors independently associated with UGIB included cyanosis in the neonate [OR 5.8; (95% CI; 1.8 - 19.1) p-value 0.004], neonatal seizures [OR 12.6; (95% CI 2.3 - 70.5); p-value 0.004] and birth asphyxia [OR 6.3; (95% CI 1.9 - 21.6); p-value 0.003]. CONCLUSIONS: In the first seven days of life, UGIB occurred in 1:4 neonates. Factors independently associated with UGIB included birth asphyxia, cyanosis in the neonate and neonatal seizures.

Aetiology, risk factors and immediate outcome of bacteriologically confirmed neonatal septicaemia in Mulago hospital, Uganda.

BACKGROUND: Neonatal septicaemia remains a major cause of morbidity and mortality. The aetiology, risk factors and outcome of this problem need to understood. OBJECTIVE: To determine the aetiology, risk factors and immediate outcome of bacteriologically confirmed neonatal septicaemia in Mulago hospital. METHODS: Blood cultures were aseptically obtained from neonates presenting with clinical sepsis by WHO criteria to Mulago during a five month period between July and November 2002. Blood was placed in Brain Heart Infusion media and incubated within 30 minutes. Subcultures were plated daily up to 7 days on blood, chocolate and MacConkey agar and incubated in aerobic and 5% carbon dioxide conditions. Pure colonies were identified by Gram stain and biochemical tests and antibiotic sensitivities were obtained. RESULTS: Gram positive organisms were predominant (69.2%) followed by E. coli (17%) and Group B Streptococci (GBS) (7%). Staphylococcus aureus and E. coli dominated isolates in early and late onset sepsis. S. aureus was more sensitive to gentamicin than to cloxacillin. The sensitivity of E. coli to ceftriaxone was 94.1%. Factors significantly associated with neonatal septicaemia were male sex, history of convulsions, hypoglycaemia, lack of antenatal care, late onset sepsis and umbilical pus discharge. Mortality in sepsis cases was 18.1%, and 84% of deaths occurred in the first 2 days of admission. Hypoglycaemia was significantly associated with death (p < 0.01). CONCLUSION: S. aureus predominates the aetiology of neonatal septicaemia followed by E.coli. Most deaths occur in the first 48 hours of admission and hypoglycaemia is significantly associated with death.