The Ballard Maturational Score was refined and expanded to achieve greater accuracy and to include extremely premature neonates. To test validity, accuracy, interrater reliability, and optimal postnatal age at examination, the resulting New Ballard Score (NBS) was assessed for 578 newly born infants and the results were analyzed. Gestational ages ranged from 20 to 44 weeks and postnatal ages at examination ranged from birth to 96 hours. In 530 infants, gestational age by last menstrual period was confirmed by agreement within 2 weeiks with gestational age by prenatal ultrasonography (C-GLMP). For these infants, correlation between gestational age by NBS and C-GLMP was 0.97. Mean differences between gestational age by NBS and C-GLMP were 0.32±1.58 weeks and 0.15±1.46 weeks among the extremely premature infants (<26 weeks) and among the total population, respectively. Correlations between the individual criteria and C-GLMP ranged from 0.72 to 0.82. Interrater reliability of NBS, as determined by correlation between raters who rated the same subgroup of infants, was 0.95. For infants less than 26 weeks of gestational age, the greatest validity (97% with 2 weeks of C-GLMP) was seen when the examination was performed before 12 hours of postnatal age. For infants at least 26 weeks of gestational age, percentages of agreement with C-GLMP remained constant, averaging 92% for all postnatal age categories up to 96 hours. The NBS is a valid and accurate gestational assessment tool for extremely premature infants and remains valid for the entire newborn infant population.
To determine the agreement between HNNE and TIMP at TCA for preterm infants born <32+0 weeks' gestation, and to evaluate their correlation to PDMS-2 at 12-month corrected age (CA).
Infants born between November 2013 to June 2022 who had both HNNE and TIMP performed at TCA of 37+0–41+6 weeks gestation, and motor outcome assessed using the PDMS-2 at 12-month old were enrolled. The HNNE and 12-month PDMS-2 findings were categorized as optimal vs sub-optimal. TIMP was categorized as typical vs atypical. Cohen's kappa was used to determine the agreement between HNNE and TIMP. Sensitivity analysis and Receiver Operating Characteristic (ROC) curves were used to evaluate the predictive values of HNNE and TIMP on motor outcome at CA of 12-months.
HNNE and TIMP done on 125 infants at TCA do not show reliable agreement. HNNE demonstrated slight and fair agreement with the 12-month Total Motor Quotient (TMQ) and Fine Motor Quotient (FMQ) of the PDMS-2 respectively. TIMP at TCA demonstrated fair agreement with all sub-domains of motor function on PDMS-2 at 12-months. In comparison with TIMP, HNNE at TCA is more sensitive at predicting suboptimal total, gross and fine motor outcomes at 12-month CA with sensitivity of 68.4 %, 51.9 %, and 83.3 % vs 44.4 %, 31.8 % and 53.3 % respectively. Atypical TIMP at TCA is more specific for suboptimal total, gross and fine motor outcomes at 12-month CA with specificity of 90.3 %, 89 % and 90.5 % respectively.
Neurobehavioral assessments at TCA using HNNE and TIMP were predictive of suboptimal fine motor quotient at CA of 12-months with AUC of 0.760 (p = 0.011) and 0.718 (p = 0.032) respectively. The difference in AUC between the 2 instruments of 0.042 was not statistically significant (p = 0.741).
While the HNNE and TIMP done at TCA did not demonstrate significant agreement, suboptimal HNNE and atypical TIMP at TCA were predictive of suboptimal FMQ on PDMS-2 at 12-month CA.
The cornerstone of malaria prevention in pregnancy, intermittent preventive treatment (IPTp) with sulfadoxine–pyrimethamine, is contraindicated in women with HIV who are receiving co-trimoxazole prophylaxis. We assessed whether IPTp with dihydroartemisinin–piperaquine is safe and effective in reducing the risk of malaria infection in women with HIV receiving co-trimoxazole prophylaxis and antiretroviral drugs.
For this randomised, double-blind, placebo-controlled clinical trial, women with HIV attending the first antenatal care clinic visit, resident in the study area, and with a gestational age up to 28 weeks were enrolled at five sites in Gabon and Mozambique. Participants were randomly assigned (1:1) to receive either IPTp with dihydroartemisinin–piperaquine at each scheduled antenatal care visit plus daily co-trimoxazole (intervention group) or placebo at each scheduled antenatal care visit plus daily co-trimoxazole (control group). Randomisation was done centrally via block randomisation (block sizes of eight), stratified by country. IPTp was given over 3 days under direct observation by masked study personnel. The number of daily IPTp tablets was based on bodyweight and according to the treatment guidelines set by WHO (target dose of 4 mg/kg per day [range 2–10 mg/kg per day] of dihydroartemisinin and 18 mg/kg per day [range 16–27 mg/kg per day] of piperaquine given once a day for 3 days). At enrolment, all participants received co-trimoxazole (fixed combination drug containing 800 mg trimethoprim and 160 mg sulfamethoxazole) for daily intake. The primary study outcome was prevalence of peripheral parasitaemia detected by microscopy at delivery. The modified intention-to-treat population included all randomly assigned women who had data for the primary outcome. Secondary outcomes included frequency of adverse events, incidence of clinical malaria during pregnancy, and frequency of poor pregnancy outcomes. All study personnel, investigators, outcome assessors, data analysts, and participants were masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT03671109.
From Sept 18, 2019, to Nov 26, 2021, 666 women (mean age 28·5 years [SD 6·4]) were enrolled and randomly assigned to the intervention (n=332) and control (n=334) groups. 294 women in the intervention group and 308 women in the control group had peripheral blood samples taken at delivery and were included in the primary analysis. Peripheral parasitaemia at delivery was detected in one (<1%) of 294 women in the intervention group and none of 308 women in the control group. The incidence of clinical malaria during pregnancy was lower in the intervention group than in the control group (one episode in the intervention group vs six in the control group; relative risk [RR] 0·12, 95% CI 0·03–0·52, p=0·045). In a post-hoc analysis, the composite outcome of overall malaria infection (detected by any diagnostic test during pregnancy or delivery) was lower in the intervention group than in the control group (14 [5%] of 311 women vs 31 [10%] of 320 women; RR 0·48, 95% CI 0·27–0·84, p=0·010). The frequency of serious adverse events and poor pregnancy outcomes (such as miscarriages, stillbirths, premature births, and congenital malformations) did not differ between groups. The most frequently reported drug-related adverse events were gastrointestinal disorder (reported in less than 4% of participants) and headache (reported in less than 2% of participants), with no differences between study groups.
In the context of low malaria transmission, the addition of IPTp with dihydroartemisinin–piperaquine to co-trimoxazole prophylaxis in pregnant women with HIV did not reduce peripheral parasitaemia at delivery. However, the intervention was safe and associated with a decreased risk of clinical malaria and overall Plasmodium falciparum infection, so it should be considered as a strategy to protect pregnant women with HIV from malaria.
European and Developing Countries Clinical Trials Partnership 2 (EDCTP2) and Medicines for Malaria Venture.
For the Portuguese and French translations of the abstract see Supplementary Materials section.
The aim of this study was to evaluate the influence of serum 25-hydroxyvitamin D [25(OH)D] levels at birth in postnatal growth at discharge and 12 mo of corrected age in preterm infants.
This prospective cohort included 63 preterm newborns born before 34 gestational weeks evaluated from birth until 12 mo of corrected age. The serum 25(OH)D levels in umbilical cord blood and from their mothers were evaluated at delivery.
The mean 25(OH)D levels in preterm newborns were higher than maternal levels (24.8 ± 13.3 ng/mL versus 21 ± 10.2 ng/mL, P < 0.001) and showed a moderate correlation between (r = 0.548; P < 0.001). Considering the body mass index Z-score at 12 mo, 3 (10%), 25 (83%), and 2 (7%) of the preterm infants were thin, had normal body mass index, and were overweight, respectively. The 25(OH)D levels in the umbilical cord did not influence the anthropometric indicators at hospital discharge and 12 mo of corrected age. We observed improvement in all anthropometric indicators assessed over the months, and there was no difference between preterm infants with 25(OH)D levels >20 ng/mL and <20 ng/mL in the umbilical cord.
The results of this study suggested that the 25(OH)D serum levels in the umbilical cord did not influence postnatal growth from birth to the first year of life in preterm infants. There was a direct association between maternal and umbilical cord serum 25(OH)D levels.
The aim of this study is to develop predictive body fat mass models, one for newborns and one for infants, using air displacement plethysmography as a reference method.
The study was carried out with 125 newborns (1–5 d of age) and 71 infants (≥3–6 mo). The stepwise method was used to estimate the final model from the predictors of sex, weight, length, triceps skinfold, waist circumference, mean arm circumference, and gestational age. The quality of the models was evaluated by the determination coefficient, variance inflation factor, and residual analysis. The paired t test and Bland-Altman plot were used to assess the agreement between observed and estimated values.
The final model for newborns was - 0.76638 + 0.2512 * weight (kg) + 0.0620 * PCT (mm) + 0.0754 * gender (R² = 70%) and the final model for infants: -2.22748 + 0.4928 * weight (kg) + 0.0737 * TSF (mm) + 0.2647 * gender (R² = 84%).
This work determined equations to estimate the BFM of term newborns and infants. The models can be used in clinical practice, especially in health units without access to technologies for measuring body composition, adding important information for nutritional monitoring.
Supported in part by National Institutes of Health grants HD 11725 (Diabetes in Pregnancy), HD 20748 (Perinatal Emphasis Research Center), and HD 07200 (Research Training in Perinatology), and by U.S. Public Health Service grants MCH MCT 174 (Training in Perinatal Care and Research) and MCH ODH 173 (CHD Maternal and Infant Care Project).
