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1.
BMC Med Educ ; 23(1): 743, 2023 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-37817195

RESUMO

BACKGROUND: Neonatal resuscitation training in a simulated delivery room environment is a new paradigm in pediatric medical education. The purpose of this research is to highlight team-based simulation as an effective method of teaching neonatal resuscitation to senior pediatric residents. METHODS: In an intervention educational study, we evaluated the impact of team-based simulation training in the development of neonatal resuscitation. A team consisting of a three-person group of senior pediatric residents performed neonatal resuscitation on a low-fidelity newborn simulator based on the stated scenario. Video-based structured debriefing was performed and followed by the second cycle of scenario and debriefing to evaluate the feasibility of conducting team-based simulation training in a lesser-resourced environment. Evaluation criteria included megacode scores which is a simulation performance checklist, pre-and post-test scores to evaluate residents' knowledge and confidence, the survey checklist as a previously developed questionnaire assessing residents' satisfaction, and debriefing from live and videotaped performances. Four months after the end of the training course, we measured the behavioral changes of the residents by conducting an OSCE test to evaluate post-training knowledge retention. Mean ± SD was calculated for megacode, satisfaction (survey checklist), and OSCE scores. Pre- and post-program gains were statistically compared. The first three levels of Kirkpatrick's training effectiveness model were used to evaluate the progress of the program. RESULTS: Twenty-one senior residents participated in the team-based simulation. The mean ± SD of the megacode score was 35.6 ± 2.2. The mean ± SD of the overall satisfaction score for the evaluation of the first level of the Kirkpatrick model was 96.3 ± 3.7. For the evaluation of the second level of the Kirkpatrick model, the pre-posttest gain in overall confidence score had a statistically significant difference (P = 0.001). All residents obtained a passing grade in OSCE as an evaluation of the third level. CONCLUSIONS: Team-based simulation training in neonatal resuscitation improves the knowledge, skills, and performance of pediatric residents and has a positive effect on their self-confidence and leadership skills. There is still a need to investigate the transfer of learning and abilities to real-life practice, and further research on cost-effectiveness and impact on patient outcomes is warranted.


Assuntos
Internato e Residência , Treinamento por Simulação , Humanos , Recém-Nascido , Criança , Ressuscitação/educação , Avaliação Educacional , Aprendizagem , Competência Clínica
2.
Clin Med Insights Pediatr ; 17: 11795565231196771, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37712054

RESUMO

Background: Neonatal intestinal obstruction is a challenging issue, especially in developing countries. There is an apparent difference in the etiology, complications, and mortality of intestinal obstruction in neonates in different countries. Objectives: We aimed to describe the causes, early postoperative outcomes, and predictors of morbidities in neonates with intestinal obstruction in a tertiary neonatal intensive care unit (NICU) in Iran. Design & methods: We conducted a retrospective study on neonates who were admitted with intestinal obstruction requiring surgery in the NICU of Boo-Ali Sina Hospital in northern Iran during 2018 to 2022. Demographic and clinical characteristics of the newborns, final diagnosis, postoperative complications, and mortality rate were documented. Also, the relationship between postoperative complications and risk factors, including birth weight, gestational age, and surgical intervention time, was evaluated. Results: A total of 169 neonates with intestinal obstruction requiring surgery were admitted with a male ratio of 60.9% and mean age of 3.85 ± 8.01 days. Imperforate anus with a prevalence of 42% was the most common cause of neonatal intestinal obstruction, followed by Hirschsprung's disease and duodenal atresia. Death after surgery occurred in 4.1% of the patients. Sepsis with a prevalence of 1.4% was the most common early postoperative complication. The late surgical intervention had a statistically significant relationship with the increase in postoperative sepsis (P = .048). Conclusion: The time of surgical intervention is the main predictor of complications in neonatal intestinal obstruction, so prompt diagnosis and timely treatment of these babies can significantly improve the prognosis. It is also necessary to improve access to pediatric surgery services in developing countries.

3.
J Neonatal Nurs ; 2023 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-37362911

RESUMO

Eleven newborns infected with COVID-19 delta variant admitted to a hospital in northern Iran during the sixth wave were evaluated. Fever, poor breastfeeding, lethargy, and lung involvement were the most prevalent symptoms in COVID-19 delta variant infected neonates. Infected mothers may be a main cause of infection for neonates.

4.
Health Serv Res Manag Epidemiol ; 10: 23333928231180561, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37347050

RESUMO

Introduction: Conflicting reports for preterm birth and stillbirth during the lockdown imposed during the COVID-19 pandemic have emerged. Most of the studies are related to the initial waves of the pandemic. Objectives: This study aims to evaluate changes in preterm birth and stillbirth rates during various waves of COVID-19 in northern Iran. Methods: This is a retrospective cohort study to evaluate preterm birth and stillbirth rate based on weight distribution per 1000 live births during lockdown periods in 5 peaks of the COVID-19 pandemic using the regional data registration system at Mazandaran University of Medical Sciences in northern Iran. We compared these rates with the corresponding months 4 years before the pandemic. The odds ratio for the primary outcome was estimated by logistic regression. Results: We observed an overall increased rate of preterm birth during the pandemic compared to the pre-pandemic period (4.7% vs 2.8%, P < .001). The overall stillbirth rate increased during the COVID-19 pandemic compared to the pre-pandemic period (7.48/1000 vs 5.41/1000, odds ratio: 1.38 [1.21-1.57]). This increase in the rate of stillbirth was significantly observed in the fifth wave of the COVID-19 pandemic (P < .001). Conclusion: Our study showed that adverse pregnancy outcomes increased during lockdown periods of a global pandemic. Further studies from geographically diverse regions to evaluate different behavior changes during pregnancy and access to prenatal services, and its impact on pregnancy outcomes is recommended.

5.
Clin Med Insights Case Rep ; 16: 11795476231151330, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36726424

RESUMO

Diazoxide is one of the FDA-approved pharmacologic treatments for hyperinsulinemic hypoglycemia, however, its adverse effects in infants are not well described. We reported a 37-week-old boy with the diagnosis of hypoglycemia. We started a dextrose infusion, but we used oral diazoxide, due to hypoglycemia episodes despite the increase in dextrose intake. The newborn had a normoglycemic condition after gradually increasing the diazoxide dose to 15 mg/kg/day. He was fully breastfed and discharged at 14 days of age with ongoing diazoxide. In weekly serial clinical follow-ups, the parents noticed an increase in the growth of forehead and facial hair that was diagnosed as diazoxide-induced hypertrichosis. Diazoxide was gradually tapered, and hypertrichosis continued until 1 month after dioxide discontinuation. Diazoxide use in NICU settings has increased over time. Diazoxide has many side effects, one of which is hypertrichosis. Many diazoxide side effects have been reported in adults or children and few studies have reported the prevalence of these adverse effects of diazoxide in neonates and infants.

6.
Glob Pediatr Health ; 10: 2333794X231156055, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36814535

RESUMO

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is one of the causes of severe hyperbilirubinemia, prolonged jaundice, and bilirubin-induced encephalopathy in neonates. In a randomized controlled trial, we evaluated the effect of oral ursodeoxycholic acid (UDCA) on indirect hyperbilirubinemia in G6PD-deficient neonates requiring phototherapy. Intervention group I (N = 45; received phototherapy and 10 mg/kg/day UDCA), Intervention group II (N = 40; received phototherapy and 20 mg/kg/day UDCA), and a control group (N = 49; received phototherapy and placebo). Levels of total serum bilirubin (TSB) in all 3 groups decreased significantly over time (P = .001) but the level of TSB at different hours after admission and the duration of phototherapy did not differ significantly between the 3 groups. After discharge, the 2 intervention groups had a significantly lower rate of readmission than the control group (P = .001). No significant difference was observed between the 10 and 20 mg/kg/day groups. Further evaluation is recommended, especially in terms of the pharmacokinetics of UDCA in neonates. Trial registration number: IRCT20091201002801N4, prospectively registered on 2019-06-1.

7.
Environ Technol ; 44(5): 670-685, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34606412

RESUMO

ABSTRACTAn innovative photocatalytic thin film nanocomposite (TFN) membrane was prepared and used for the simultaneous separation/degradation of methylene blue (MB) under UV irradiation. For this purpose, we used the sol-gel method to prepare the TiO2/MWCNTs nanophotocatalyst and added to the 1,3-phenylenediamine (MPD) solution during interfacial polymerization (IP) of 1,3,5-benzenetricarbonyl chloride (TMC) and 1,3-phenylenediamine monomers on the polysulfone (PSF) support. Using scanning electron microscopy (SEM) analysis and studying the cross-sectional images of membrane samples, it was revealed that the polyamide (PA) thin layer was well fabricated over the support membrane. The attendance of the TiO2/MWCNTs nanophotocatalyst in the PA thin layer of TFN samples was also proved using EDX (energy-dispersive X-ray) analysis. According to the results of the contact angle (CA), it is clear that the hydrophilicity of membrane samples first increased and then decreased by enhancing the TiO2/MWCNTs nanophotocatalyst content in the PA thin layer. In comparison with the pristine thin film composite (TFC) membrane, TFN samples showed higher water flux and MB removal when they were exposed to UV light. Finally, it turned out that the TFN membrane comprising 0.2 wt. % TiO2/MWCNTs nanophotocatalyst (TFN 0.2) had the foremost efficiency among TFNs with the water flux of 13 L/m2·hr and dye separation/degradation of almost 100% under UV irradiation.


Assuntos
Azul de Metileno , Nanocompostos , Nylons , Água
8.
Clin Case Rep ; 10(8): e6232, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35957770

RESUMO

We presented a case of neonatal appendicitis in a 22-day-old premature infant. The patient developed abdominal distension and perforation was suspected. The patient was transferred to the operating room with a diagnosis of peritonitis. Normal bowel loops were seen during surgery. Gangrenous appendicitis was seen. An appendectomy was performed.

9.
Ann Med Surg (Lond) ; 78: 103839, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35646336

RESUMO

Background: Despite the rapid increase in knowledge about coronavirus disease 2019 (COVID-19), there is limited data on vertical transmission, viral loads in mother-neonate pairs, and health outcomes. We aimed to describe the characteristics, viral loads, and short-and mid-term outcomes of neonates born to mothers with confirmed COVID-19 infection in northern Iran. Materials and methods: In a cross-sectional study, we prospectively collected and analyzed the clinical features, reverse transcription-polymerase chain reaction (RT-PCR) results, viral loads, and outcomes of 60 neonates delivered by 58 SARS-CoV-2 infected pregnant women in maternity hospitals of Mazandaran University of Medical Sciences (northern Iran) during first three waves of the pandemic from March 1 to December 31, 2020. We assessed neonates' short and mid-term outcomes up to 24 months after the pandemic. We also described the timing of mother-to-infant transmission based on the classification presented by the World Health Organization. Results: Of the 17767 deliveries, 58 mothers had confirmed and probable COVID-19 infection. Twenty (33.3%) neonates were positive for SARS-CoV-2, two of whom had possible in utero transmission. Twenty-five (41.2%) neonates were preterm, most of whom were born during the first and second waves in which mothers were critically ill. 19 (31.7%) patients needed resuscitation in the delivery room. 34 (56.7%) neonates were isolated in the neonatal intensive care unit. We observed a significant relationship between the maternal and neonatal viral load (correlation coefficient = 0.983, P = 0.00). No neonatal death was observed and all babies had a good outcome. Conclusions: The results showed that vertical transmission of SARS-CoV-2 is possible but rare. Regional factors and severity of mother's disease may influence the clinical course of neonates. With increasing experience, proper observance of health precautions, and rapid development of evidence-based response systems for regional and global disasters, the transmission rate of SARS-CoV-2 from mother to newborn is reduced.

10.
Eur J Obstet Gynecol Reprod Biol X ; 15: 100149, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35493996

RESUMO

Objective: Attachment is a socio-emotional relationship between the mother and infant that increases the probability of a preterm infant's survival. This study aimed to evaluate the effectiveness of Kangaroo Mother Care (KMC) on maternal attachments of mothers with premature infants. Study design: This quasi-experimental study was performed on 100 mothers of premature infants who were admitted to neonatal intensive care units. A questionnaire comprising demographic information and the Maternal Attachment Scale were used as data collection tools. All data analysis was performed using SPSS software version 25. Significant level is considered P < 0.05. Results: After the intervention, the levels of maternal attachment of mothers in the intervention group were significantly higher than in the control group (47.7 ± 2.9vs. 40.4 ± 5.4, P = 0.003). After the intervention, the infants in the intervention group has a significantly higher number of breastfeeding than the control group (10.6 ± 1.8 vs. 8.2 ± 1.6, P = 0.000). Moreover, the infant of the intervention group had a statistically significant higher weight at discharge time (2164.4 ± 481.1 vs. 1965.2 ± 372, P = 0.042). Conclusion: The results of the present study showed that Kangaroo Mother Care can be used to improve the maternal attachments in mothers with premature infants. It improves the breastfeeding and weight gain status in infants as well.

11.
Ann Med Surg (Lond) ; 76: 103573, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35495371

RESUMO

Background: Post-extubation-atelectasis (PEA) is a common problem after the removal of an endotracheal tube in neonates which increases the rate of extubation failure. Different techniques have been introduced for the prevention of PEA. One technique is the removal of the endotracheal tube by negative or positive gradients of pressure. No RCT has yet been done to compare the use of these two methods in neonates. So this study aimed to compare the role of positive and negative pressure during extubation of neonates on the prevention of PEA. Materials and methods: We enrolled 100 newborns in this RCT that required at least 24 h of mechanical ventilation. The endotracheal tube in one group was removed by a T-Piece resuscitator at a PEEP level of 5 CmH2o while in another group extubation was done applying suction pressure of 100 mmHg by random selection. Prevalence of PEA in CXRs after extubation was compared between the two groups. Results: The prevalence of PEA in the extubation of the positive pressure group (24%) was significantly lower than that of the negative pressure group (46%) (p = 0.024). Extubation failure was found to be lower in the positive pressure group (6% versus 20% P = 0.037). No significant difference was observed between the two groups in the prevalence of apnea, pneumothorax, and death at 3 days after extubation. Conclusion: The use of positive pressure during removal of the endotracheal tube in newborn infants reduced the rate of PEA compared with the negative pressure so extubation by a positive pressure is recommended in neonates.

12.
J Glob Antimicrob Resist ; 30: 474-479, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35640868

RESUMO

OBJECTIVES: Vancomycin-resistant enterococcus (VRE) is an emerging drug-resistant organism responsible for increasing nosocomial infections. Few data are available on the epidemiology of VRE colonization or infection in neonates, and is of recent interest. This study analyzes the prevalence of neonatal VRE colonization in a neonatal intensive care unit (NICU), and describes risk factors and molecular phenotypes associated with VRE colonization. METHODS: We performed a prospective epidemiological study on neonates admitted to an NICU. We compared neonates with VRE isolates detected in rectal swab cultures to those without. Association of VRE colonization with risk factors was tested by using univariate and multivariate methods. RESULTS: During a period of 18 months, amongst 180 neonates enrolled in the study, 76 (42.2%) were colonized by VRE. VRE isolates were resistant to amikacin in 68%, gentamicin in 26%, and ampicillin in 17.1% of cases. Molecular analysis showed the vanA gene in all isolates. Two VRE-positive patients developed infection during the observation time. No deaths occurred during this period. Prematurity (P = 0.023), low birth weight (P = 0.019), history of admission in other hospitals (P = 0.00), and antibiotic therapy for more than seven days (P = 0.01) were identified as risk factors for VRE colonization. CONCLUSION: Newborn susceptibility to early colonization with VRE in NICUs is increased in preterm and low birth weight newborns. All VRE colonization in the NICU was related to the acquisition of the vanA gene. Adherence to infection control policies and antimicrobial stewardship strategies are of the highest importance.


Assuntos
Infecções por Bactérias Gram-Positivas , Enterococos Resistentes à Vancomicina , Peso ao Nascer , Infecções por Bactérias Gram-Positivas/epidemiologia , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Irã (Geográfico)/epidemiologia , Prevalência , Estudos Prospectivos , Encaminhamento e Consulta , Fatores de Risco , Enterococos Resistentes à Vancomicina/genética
13.
Clin Case Rep ; 10(3): e05547, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35280079

RESUMO

The case was a 4-day-old boy referred to the hospital with a diagnosis of Pierre Robin Sequence and with airway Obstruction. Using a laryngoscope in the hyperextended position and putting pressure on the cricoid, the vocal cords were visualized, and with the help of an assistant, the intubation was performed.

14.
Clin Case Rep ; 10(1): e05295, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35079392

RESUMO

We present a rare congenital condition in a Persian newborn characterized by the unilateral everted upper eyelid. This report aimed to create awareness among neonatologists and ophthalmologists who are first-time viewers of this condition and lead them to choose the appropriate management.

15.
Ann Med Surg (Lond) ; 72: 103119, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34840782

RESUMO

INTRODUCTION: and importance: Limited data are available about various effects of COVID-19 on pregnancy. On the other hand, the COVID-19 pandemic could exacerbate anxiety or schizophrenia symptoms. CASE PRESENTATION: The patient is a 5-day-old newborn, whom his mother suffers from schizophrenia, depression and anxiety disorders. The young pregnant mother gets delusions of being infected with Covid-19, thus attempts suicide with Sertraline, Clonazepam, Quetiapine and Rispeirdone, although she was in the last week of pregnancy. The newborn baby referred to our neonatal ward with seizure and apnea. Phenytoin and caffeine were administered leading to some degree of symptom relief, but due to the dermatologic reactions of phenytoin, they were replaced with levetiracetam. CLINICAL DISCUSSION: The Covid-19 may increase levels of anxiety and depression or exacerbation of schizophrenia symptoms, especially in pregnant women suffering from mental disorders. In addition, there are evidence supporting the occurrence of neonatal malformations as a result of exposure to antipsychotic drugs during the first trimester of pregnancy. CONCLUSION: Investigating the role of antidepressant and antipsychotic drugs in the perinatal period, especially near delivery has received less attention so far; thus further studies are required to determine the safety of these drugs.

16.
Clin Case Rep ; 9(8): e04664, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34466243

RESUMO

Simultaneous presentation of omphalocele, patent urachus, and umbilical cyst is very rare. There is wide range of differential diagnosis for umbilical cyst. Accurate assessment of umbilical cysts is important to evaluate other abnormalities.

17.
Indian J Pharmacol ; 53(2): 108-114, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34100394

RESUMO

OBJECTIVES: Despite extensive caffeine use in preterm infants, the pharmacokinetics (PKs) data are limited because of the studies are complicated to do in these patients. This research was investigated the PK profile of two various dosages of caffeine in premature neonates. MATERIALS AND METHODS: The PK values of caffeine in premature neonates with Apnea were predicted by using all of computer-based simulation (Simcyp®), population-based PK, and modeling (P-Pharm®). We assayed the plasma levels of caffeine in two groups. The information was analyzed utilizing nonlinear mixed-effects modeling approach. The PK parameters were assessed simulating virtual clinical considers with subjects got 20 mg. kg-1 of caffeine in both groups, which was followed by a 5 mg. kg-1 once daily in Group 1 or 2.5 mg. kg-1 twice daily in Group 2. All statistical analysis was executed utilizing SSPS issue 19 and a P value of 0.05 was chosen significance. RESULTS: In the present study, the means CL, volume of distribution, and T1/2 of caffeine in preterm infants were 0.0476 L. h-1, 1.1081 L, 16.2284 h, respectively. Whereas our simulated means by Simcyp were 0.090 L. h-1, 1.841 L, and 14.653 h in Group 1 and 16.223 h in Group 2, respectively. CONCLUSIONS: There was overall good agreement between predicted and measured PK values in our study. This study provides an initial demonstration of Simcyp simulation advantage on anticipating of PK parameters.


Assuntos
Apneia/tratamento farmacológico , Cafeína/farmacocinética , Recém-Nascido Prematuro/metabolismo , Apneia/metabolismo , Cafeína/administração & dosagem , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Modelos Biológicos
18.
J Med Case Rep ; 15(1): 213, 2021 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-33892788

RESUMO

BACKGROUND: Vertical transmission of coronavirus disease 2019 (COVID-19) from mother to newborn infant is doubtful, and very little is known about disease severity and neonatal outcome. CASE PRESENTATION: We present a preterm Iranian infant born to a Persian mother with severe COVID-19 pneumonia. The mother underwent cesarean delivery, and amniotic fluid yielded a positive result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by real-time reverse transcription polymerase chain reaction (RT-PCR). The newborn infant showed early-onset infection with SARS-CoV-2 confirmed on pharyngeal swabs by RT-PCR assay within 24 hours after birth, suggesting vertical transmission. Unfortunately, the mother died 14 days after delivery. We describe the clinical course and outcome of the infant up to 7 months of age. CONCLUSION: COVID-19 infection in pregnant women may increase maternal morbidity, mortality and possibly vertical transmission in severe cases. However, it does not seem to progress to serious early or late neonatal complications.


Assuntos
COVID-19/diagnóstico , Transmissão Vertical de Doenças Infecciosas , Complicações Infecciosas na Gravidez/diagnóstico , Nascimento Prematuro , Líquido Amniótico/virologia , COVID-19/patologia , Cesárea , Evolução Fatal , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Irã (Geográfico) , Gravidez , Complicações Infecciosas na Gravidez/virologia , Resultado da Gravidez , Ressuscitação , Adulto Jovem
19.
Cureus ; 13(3): e13699, 2021 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-33833919

RESUMO

The separation of the mother-infant pair during the immediate postpartum period has been shown to impair the initiation and sustenance of breastfeeding. For critically ill mothers with coronavirus disease 2019 (COVID-19), the imposed isolation generates anxiety for their health and that of the offspring. In this study, we present a few cases where a favorable outcome was observed through a telehealth initiative for mothers with severe COVID-19 pneumonia, which involved sharing pictures and videos of newborn infants with the mothers during the ongoing severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) pandemic in a maternity hospital in northern Iran. In addition to the subjective maternal wellbeing offered by the visual and auditory cues from the infant, this technology-assisted telelactation'/'mobile-lactation'/'e-lactation' could potentially enhance the mother's capacity to initiate emotional bonding with the infant and be an adjunct in achieving and maintaining her lactation goals while offering the best nutritional choice for the infant.

20.
J Ethnopharmacol ; 236: 240-249, 2019 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-30853647

RESUMO

ETHNOPHARMACOLOGICAL RELEVANCE: Cotoneaster nummularioides Pojark manna (Shir-e-Khesht) is popular in Persian medicine. Different effects of some Cotoneaster species manna include antibacterial, antioxidant, anticancer, and hepatoprotective effects, as well as bilirubin serum levels reduction. Cotoneaster species manna is used in many parts of Iran as a laxative and accelerates the passage of meconium. Neonatal jaundice has relatively costly and sometimes invasive therapeutic interventions, which its prevention from becoming severe cases can be a priority in neonatal medicine. AIM OF THE STUDY: The aim of this study was to evaluate the effectiveness of an herbal product (Purgative Manna, native to Iran and Asian countries) in preventing severe cases of jaundice and reducing total bilirubin levels in neonates. MATERIALS AND METHODS: This randomized double-blind controlled clinical trial included full-term babies. Four hundred and forty-five (445) eligible neonates were assigned to two groups using the block balanced randomization method; 222 neonates received the Purgative Manna product as drops, and 223 neonates received placebo drops. The neonates received a dose of 5 drops per kilogram of neonatal weight (divided into three doses per day) for three days. The treatment period was three days, and a 24-h (three times) examination was performed to measure the initial outcome of the trial (i.e., the total serum bilirubin level). The secondary outcomes of this trial were the need for hospitalization due to jaundice and/or phototherapy from 4 to 14 days after birth, the frequency of defecation within 24 h, and the triple complications of diarrhoea, dehydration symptoms, and abdominal colic. RESULTS: In this study, 220 neonates in the Purgative Manna product group and 222 neonates in the placebo group completed their interventions within the predicted period of the study. At the end of study, the total bilirubin level in the Purgative Manna treated group was significantly lower than that of the placebo group. The difference between the mean total bilirubin levels of the two groups was approximately 2.1 mg/dl on the third day after treatment, with an effect size of 0.79 (95% CI: 0.06-0.98). The relative risk for reducing the need for hospitalization or phototherapy in the group treated with Purgative Manna drops was 0.26, compared with the placebo group. The risk of occurrence of severe jaundice or phototherapy in the Purgative Manna group was 75% lower than that of the placebo group. The median frequency of defecation in the intervention group at three time intervals in the first, second and third days after treatment was 1-2 times more than that of the comparison group (p < 0.001). CONCLUSIONS: Meanwhile, considering the fact that one in every eight neonates who used the product avoided having a severe and high-risk case of jaundice or the need for phototherapy intervention (even through an exchange transfusion), the use of Purgative Manna drops can be recommended; however, further study is necessary.


Assuntos
Bilirrubina/sangue , Misturas Complexas/administração & dosagem , Icterícia Neonatal/prevenção & controle , Medicina Tradicional/métodos , Rosaceae/química , Administração Oral , Cólica/induzido quimicamente , Cólica/epidemiologia , Misturas Complexas/efeitos adversos , Desidratação/induzido quimicamente , Desidratação/epidemiologia , Diarreia/induzido quimicamente , Diarreia/epidemiologia , Método Duplo-Cego , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Recém-Nascido , Irã (Geográfico) , Icterícia Neonatal/sangue , Icterícia Neonatal/terapia , Masculino , Fototerapia/estatística & dados numéricos , Placebos/administração & dosagem , Resultado do Tratamento
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