Protocol and Researcher’s Relationship with Institutional Review Board

The document of ethical approval is an important official requirement for research involving human participants worldwide. It is the process whereby an investigator submits the full research proposal and related documents including detailed informed consent process to an independent Institutional Review Board (IRB) for scrutiny. The process of seeking review and approval is necessary to ensure adequate measure are in place to safeguard and protect research participants as entrenched in the principles of The Declaration of Helsinki and The Belmont Report. It is the responsibility of every clinical researcher to obtain ethical approval, therefore, their obligation to understand the process of review and establish relationship with local IRB in order to enhance smooth review and approval. This article, therefore, explains clinical research and distinguishes between research and clinical care, clarifies briefly what constitutes a study protocol and describes the researchers' relationship with IR

Adequacy of Bristol stool form scale in the assessment of stools by mothers of healthy infants in Ibadan, Nigeria

Background: An important complaint of mothers is the stool form of their infants. In the evaluation of stool forms, healthcare workers usually depend on mothers’ reports which are subjective and influenced by interpretation bias by health care personnel. There is therefore the need for an objective method of describing stool forms. In the present study, we evaluated the utility of the 7-point Bristol Stool Form Scale (BSFS) when used by mothers of healthy Nigerian infants. Materials and Methods: The mothers of 122 healthy infants delivered at term, with infants less than six months of age attending the Infant Welfare Clinics of two health facilities in Ibadan, South West, Nigeria for routine immunisation were enrolled. Mothers were requested to identify their child’s most recent stool form using the 7-point BSFS. Results: The mean ± SD age of the 122 study infants was 80 ±41.6 days (range 4-180 days). Eighty-eight (72.1%) infants were exclusively breastfed and 34 (27.9%) were on mixed feeding. Almost all (120; 98.4%) mothers felt that the BSFS adequately described their infants’ stools. The most commonly reported stool types were T ype 6 (56.7%) and T ype 7 (33.3%). There was no association between reported stool consistency and infant feeding type, level of maternal education and number of previous babies nursed. Conclusion: This study indicated that BSFS may be a reliable tool for mothers to describe stool consistency in healthy Nigerian infants

Accuracy of mid upper arm circumference in detection of obesity among school children in Yenagoa City, South-south region of Nigeria

Background: The search for alternative method that is easier and less cumbersome than body mass index (BMI), for identification of obese individuals has been controversially discussed in recent literature. This study was carried out to determine the accuracy of Mid Upper Arm Circumference (MUAC) compared to BMI. Method: We recruited 920 children aged 5–18 years from primary and secondary schools in Yenagoa in the Niger Delta region of Nigeria using a multistage random sampling technique. Weight, height and MUAC of the children were measured using standard methods. We calculated BMI, defined obesity as BMI-for-age z- scores >2 and the corresponding cut-off values of MUAC for defining obesity were determined. Sensitivity, specificity, negative predictive values (NPV) and positive predictive values (PPV) of MUAC were determined using BMI as the gold standard. Area under the ROC (AUC) was also determined to assess MUAC’s ability to correctly identify obesity. Results: MUAC correlated positively with BMI and age, the cut-off values increased with age in both boys and girls. When compared with BMI, using sex and age group specific cut-off for MUAC, the estimated specificities were relatively higher than sensitivities in all age groups. However, the best performance of MUAC for detection of obesity was recorded for girls (AUC = 0.94, 96% CI = 0.89, 0.99) and boys (AUC = 0.89, 95% CI = 0.78, 0.99) in age group 10-14 years. Similarly, the NPV were higher than the PPV. Conclusion: The MUAC showed remarkably high accuracy for diagnostic and screening use among children aged 10-14 years but inconsistent results in other age groups

Persistence of Plasmodium falciparum HRP2 antigen after effective antimalarial therapy

Introduction: Histidine Rich Protein 2 based (HRP2-based) malaria rapid diagnostic tests (mRDTs) have been shown to perform as well as routine light microscopy, however, they are limited by some factors including persistence of HRP2 antigenemia. In this paper we report the evaluation of an HRP2-based mRDT in a prospective study that enrolled children and followed them up for 28 days. Methods: Children aged below five years, with acute episode of fever/pyrexia,were enrolled. The enrolled participants had expert malaria microscopy and RDT done at enrolment (Day 0), and on days 1, 2, 3, 7, 14, 21, and 28. The malaria RDT test was considered positive when the antigen and control lines were visible  in their respective windows, negative when only the control band was visible and invalid when the control  band was not visible. Faint test lines were considered positive. The RDT results were compared to  those of expert microscopy. Results: Two hundred and twenty-six children aged 29.2 ± 15.5 months were enrolled. The proportion of children positive by expert malaria microscopy and RDT was 100% and 95.6% respectively. During the 28 day follow up of the children the proportions positive by microscopy and RDT on days 3, 7, 14, and 28  were 1% and 94.6%, 0% and 93.5%, 0% and 91%, and 16.5% and 80.6% respectively. Gender and age dependent analysis of proportion of positive children were similar. Proportion of children with persistence of HRP2 antigen appeared to be lower in those with parasite density below 200/µL, however, this  observation requires further evaluation in larger studies. Conclusions: the study revealed a high proportion of persistence of HRP2 antigen in the children 28 days  after effective antimalarial therapy. Histidine rich protein 2 based malaria rapid diagnostic tests are not  recommended for monitoring of antimalarial therapies

Ulcerative colitis in Nigerian children: A report of two cases and review of the literature

Ulcerative colitis (UC) is a relapsing, idiopathic chronic inflammatory disorder of colon characterised by ulcerations of the colon with bleeding, mucosal crypt abscesses and inflammatory pseudo polyps associated with abdominal pain with tenesmus and significant weight loss. Ulcerative colitis has rarely been reported in sub-Saharan African children. In this report we present 2 cases of ulcerative colitis i in Nigerian children confirmed by barium enema, colonoscopy and histology. A review of the current literature on ulcerative colitis is also discussed

High prevalence of Plasmodium malariae and Plasmodium ovale in co-infections with Plasmodium falciparum in asymptomatic malaria parasite carriers in southwestern Nigeria

Asymptomatic malaria parasite carriers do not seek anti-malarial treatment and may constitute a silent infectious reservoir. In order to assess the level of asymptomatic and symptomatic carriage amongst adolescents in a highly endemic area, and to identify the risk factors associated with such carriage, we conducted a cross-sectional survey of 1032 adolescents (ages 10-19 years) from eight schools located in Ibadan, southwestern Nigeria in 2016. Blood films and blood spot filter paper samples were prepared for microscopy and DNA analysis. The prevalence of asymptomatic malaria was determined using microscopy, rapid diagnostic tests (RDTs) and PCR for 658 randomly selected samples. Of these, we found that 80% of asymptomatic schoolchildren were positive for malaria parasites by PCR, compared with 47% and 9%, determined by RDT and microscopy, respectively. Malaria parasite species typing was performed using PCR targeting the mitochondrial CoxIII gene, and revealed high rates of carriage of Plasmodium malariae (53%) and Plasmodium ovale (24%). Most asymptomatic infections were co-infections of two or more species (62%), with Plasmodium falciparum + P. malariae the most common (35%), followed by P. falciparum + P. malariae + P. ovale (21%) and P. falciparum + P. ovale (6%). Single infections of P. falciparum, P. malariae and P. ovale accounted for 24%, 10% and 4% of all asymptomatic infections, respectively. To compare the species composition of asymptomatic and symptomatic infections, further sample collection was carried out in 2017 at one of the previously sampled schools, and at a nearby hospital. Whilst the species composition of the asymptomatic infections was similar to that observed in 2016, the symptomatic infections were markedly different, with single infections of P. falciparum observed in 91% of patients, P. falciparum + P. malariae in 5% and P. falciparum + P. ovale in 4%

Aflatoxin exposure in Nigerian children with severe acute malnutrition

Aflatoxin exposure is an important public health concern in sub-Saharan Africa as well as parts of Latin America and Asia. In addition to hepatocellular carcinoma, chronic aflatoxin exposure is believed to play a role in childhood growth impairment. The most reliable biomarker of chronic aflatoxin exposure is the aflatoxin-albumin adduct, as measured by ELISA or isotope dilution mass spectrometry (IDMS). In this report, we have used high resolution LC-MS/MS with IDMS to quantitate AFB1-lysine in an extremely vulnerable population of Nigerian children suffering from severe acute malnutrition. To increase the sensitivity and reliability of the analyses, a labelled AFB1-13C6 15N2-lysine internal standard was synthesized. AFB1-lysine concentrations in this population ranged between 0.2 and 59.2 pg/mg albumin, with a median value of 2.6 pg/mg albumin. AFB1-lysine concentrations were significantly higher in stunted children (median = 4.6 pg/mg) compared to non-stunted (1.2 pg/mg), as well as in children with severe acute malnutrition (4.3 pg/mg) compared to controls (0.8 pg/mg). The median concentrations were also higher in children with kwashiorkor (6.3 pg/mg) compared to those suffering from marasmus (0.9 pg/mg). This is the first report of the use of high-resolution mass spectrometry to quantitate AFB1-lysine in humans