Dysmorphism and major anomalies are a main predictor of survival in newborns admitted to the neonatal intensive care unit in the Democratic Republic of Congo.

In Central-Africa, neonatal infections, asphyxia and prematurity are main reasons for admission to the neonatal intensive care unit and major determinants of newborn survival. Also, the outcome of newborns with congenital anomalies is expected to be poor, due to a lack of state-of-the art care. We conducted a study of 102 newborns recruited in the Neonatal Intensive Care Unit (NICU) at the University Hospitals of Kinshasa, DR Congo, to assess the impact of congenital anomalies. The presence of a major anomaly was associated with a hazard ratio of death of 13.2 (95%CI: 3.7-46.7, p < .001). In addition, the presence of three or more minor anomalies was associated with a 4.5-fold increased risk of death (95%CI: 1.1-18.6, p = .04). We conclude that like major anomalies, the presence of three or more minor anomalies should also be given particular attention and that the evaluation of dysmorphism should be promoted in NICU.

Evolution of the Thompson score during the first 6 h in infants with perinatal asphyxia.

AIM: This study aimed to determine the evolution of the Thompson score, which provides composite grading of encephalopathy signs, during the first 6 h of birth in neonates with perinatal asphyxia. METHODS: Twenty term infants with perinatal asphyxia were prospectively studied from the University Hospital of Kinshasa during a 12-month period. The Thompson score was performed after 1 h, then hourly until 6 h of birth. RESULTS: Fourteen infants had a Thompson score ≥7 and six had a score <7 after 1 h of birth. The Thompson score remained higher than 7 after 3 h in nine infants (64.3%) and in four infants (25.6%) after 6 h. After 3 h of birth, four infants moved from a score ≥7 to a score below 7. After 6 h, five infants had a score below 7. Seventy per cent of patients had a Thompson score higher than 7 after 1 h, 45% after 3 h and 20% after 6 h. CONCLUSION: The Thompson score changes over the time during the first 6 h of birth, and this should be taken into account when it is being used as an entry criterion for cooling.

A descriptive study of perinatal asphyxia at the University Hospital of Kinshasa (Democratic Republic of Congo).

BACKGROUND: Perinatal asphyxia is the third cause of neonatal death after prematurity and infection. OBJECTIVE: The purpose of this study was to determine the incidence, the etiology and the HIE score at the first day in term and near-term newborns with perinatal asphyxia at the University Hospital of Kinshasa. METHODS: 50 term and near-term neonates with perinatal asphyxia were studied prospectively after they were admitted in neonatal intensive care from November 2009 to January 2011. For each patient admitted the perinatal data were collected. Clinical assessment was performed by the Sarnat grading and the Thompson score within twenty-four hours. Medcalc® was used for statistics. RESULTS: 50 babies were scored. The median maternal age was 31 years. In 22% of the mothers preeclampsia was diagnosed. Urogenital infection, IUGR were other prenatal diagnoses. Median Apgar score was 4 after 1 minute, 5 after 5 minutes and 6 after 10 minutes. Sarnat grade 1 was seen in 16 patients, Sarnat grade 2 in 20 patients and grade 3 in 8. Thompson score in the first 24 hours was more than 7 in 60% of the patients. A good correlation was found between the Thompson score and the Sarnat grade (r: 0,77; p < 0,0001). 14 of the 50 babies died. Both Sarnat and Thompson score correlated significantly with mortality. CONCLUSION: The incidence of perinatal asphyxia at the University Hospital of Kinshasa remains high and the majority of patients had a severe HIE.

A Phase IIa Clinical Trial of 2-Iminobiotin for the Treatment of Birth Asphyxia in DR Congo, a Low-Income Country.

AIM: The main burden of hypoxic-ischemic encephalopathy falls in low-income countries. 2-Iminobiotin, a selective inhibitor of neuronal and inducible nitric oxide synthase, has been shown to be safe and effective in preclinical studies of birth asphyxia. Recently, safety and pharmacokinetics of 2-iminobiotin treatment on top of hypothermia has been described. Since logistics and the standard of medical care are very different in low-resource settings, the aim of this study was to investigate safety and pharmacokinetics of Two-IminoBiotin in the Democratic Republic of Congo (TIBC). METHODS: Near-term neonates, born in Kinshasa, Democratic Republic of Congo, with a Thompson score ≥ 7 were eligible for inclusion. Excluded were patients with (1) inability to insert an umbilical venous catheter for administration of the study drug; (2) major congenital or chromosomal abnormalities; (3) birth weight < 1800 g; (4) clear signs of infection; and (5) moribund patients. Neonates received six infusions of 2-iminobiotin 0.16 mg/kg started within 6 h after birth, with 4-h intervals, targeting an AUC0-4h of 365 ng*h/mL. Safety, defined as vital signs, the need for clinical intervention after administration of study drug, occurrence of (serious) adverse events, and pharmacokinetics were assessed. RESULTS: After parental consent, seven patients were included with a median Thompson score of 10 (range 8-16). No relevant changes in vital signs were observed over time. There was no need for clinical intervention due to administration of study drug. Three patients died, two after completing the study protocol, one was moribund at inclusion and should not have been included. Pharmacokinetic data of 2-iminobiotin were best described using a two-compartment model. Median AUC0-4h was 664 ng*h/mL (range 414-917). No safety issues attributed to the administration of 2-iminobiotin were found. CONCLUSION: The present dosing regimen resulted in higher AUCs than targeted, necessitating a change in the dose regimen in future efficacy trials. No adverse effects that could be attributed to the use of 2-iminobiotin were observed. EudraCT number 2015-003063-12.