Fetal malformations associated with exposure to mycophenolic acid during the first trimester.

Mycophenolic acid [MPA] is a powerful inhibitor of lymphocyte proliferation. Although this drug has been used across the globe for various maternal comorbidities, multiple concerns have been raised regarding its teratogenic effects. The Food and Drug Administration has changed its category to drug category D (evidence of fetal risk) in 2007. A wide range of congenital malformations in infants born to a mother using this medication have been described in the literature, but there is no specific set pattern of these malformations. We report a case of a female infant who had exposure to mycophenolate by maternal use during the initial phase of 1st trimester of her pregnancy and ended up having multiple congenital malformations. She was managed with multidisciplinary approach and was finally discharged home on respiratory support, after two months of hospital stay. The fact that our patient shared a pattern of congenital malformations with other reported cases who were exposed to mycophenolate in utero strongly suggests that mycophenolate had a causal role and that there might be an emerging fetal mycophenolate mofetil syndrome (FMMS).

Outcome of Twin Pregnancies Complicated by a Single Intrauterine Death.

Objective Single intrauterine fetal death (sIUFD) occurs in approximately 6% of twin pregnancies. If it occurs in the second and third trimesters, it places the co-twin at substantial risk, including that of preterm delivery and associated comorbidities of prematurity or neonatal death. The aim of this present study was to determine the outcome of surviving co-twins following spontaneous single intrauterine fetal death. Methods This is a retrospective, observational, cohort study that included all twin pregnancies delivered between January 2015 to December 2019 with a gestational age of 24 weeks or more. Maternal data included were: age, medical illnesses, conceivable methods, chorionicity, and complications during pregnancy. Gestational age of intrauterine fetal demise, gestational age of the surviving twin delivery, mode of delivery, and medications used during pregnancy were also recorded. Neonatal data included: gestational age, gender, birth weight, Apgar score, and complications of prematurity. Results Twenty-two pregnancies were found to be complicated by sIUFD and included in the present study (group 1), compared to 26 twins with no sIUFD (group 2). The incidence of sIUFD in twin pregnancies after 20 weeks of pregnancy was 4.4%. The gestational age (weeks) in group 1 was 34.5 (29-39) and in group 2 was 32 (26-38). The frequency of preterm delivery 81.8% in group 1 (59% monochorionic) and 69.2% (100% dichorionic) in group 2. No significant statistical differences were found between the two groups in complications of prematurity. Conclusions We conclude that delaying delivery in twin pregnancies complicated by single intrauterine demise with regular follow-up may lead to delivering infants with fewer complications of prematurity.

Ursodeoxycholic Acid and SMOFlipid for Treating Parenteral Nutrition Associated Cholestasis in Infants.

BACKGROUND:  Parenteral nutrition-associated cholestasis (PNAC) is frequently seen in preterm infants receiving total parenteral nutrition (TPN) for a long duration. The pathogenesis of PNAC is believed to be multifactorial; however, phytosterols are hepatotoxic, resulting in cholestasis. A novel lipid emulsion consisting of a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOFlipid) with a low level of phytosterols has been shown to improve cholestasis. Moreover, ursodeoxycholic acid (UDCA) has improved bile flow and normalized liver function tests. This study aimed to determine the effect of UDCA and SMOFlipid in preventing and treating PNAC in infants. METHODS:  We conducted a retrospective cohort study that included all infants who received TPN for at least five days between January 2010 and December 2018, who also received UDCA for the treatment of cholestasis, and infants who developed cholestasis but were not treated with UDCA. In addition, any infants who received SMOFlipid for parenteral nutrition during the same period were included. We recorded multiple variables, including neonatal demographic data, major medical diagnosis, liver function, medications, and maternal variables. RESULTS:  A total of 58 infants with cholestasis who received UDCA for treatment were identified. The infants were divided into two groups, Group 1 infants had gestational age (GA) of ≤32 weeks, and Group 2 had GA of >32 weeks. We found that combining SMOFlipid with UDCA resulted in a significant reduction in cholestasis duration in both groups. Infants in Group 1 who received SMOFlipid had cholestasis for a mean of 67 ± 57 days, and those who did not receive SMOFlipid had cholestasis for a mean of 145 ± 102 days (p=0.04). Infants in Group 2 who received SMOFlipid had cholestasis for a mean of 38.2 ± 28 days, and those who did not receive SMOFlipid had cholestasis for a mean of 117 ± 119 days (p=0.02). CONCLUSIONS:  According to our results, the use of UDCA and SMOFlipid reduced the duration of parenteral nutrition-associated with cholestasis in very low birth weight infants.

Effects of Probiotics and Lactoferrin on Necrotizing Enterocolitis in Preterm Infants.

Background Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality in neonates. Despite intensive research, the etiology and pathophysiology of NEC is still obscure. Evidence from recent studies and meta-analyses showed a significant role of probiotics as a prophylactic measure in reducing NEC, sepsis, and mortality. However, obstacles against the generalization of the results still remain. The aim of the study was to evaluate the role of prophylactic administration of probiotics and lactoferrin in reducing the rate of NEC in preterm infants. Methods In this retrospective cohort study, all medical records of infants born with a birth weight of 1,500 g and less who were born between 2012 and 2017 were reviewed. The enrolled infants were divided into two groups: group 1 included infants born between January 2012 and August 2014, a period before probiotics were started in our unit, and group 2 included infants born between January 2014 and December 2017 after starting probiotics and lactoferrin. Multiple variables were collected including maternal data, neonatal data, and risk factors for NEC. Results Medical records of 284 infants who met our inclusion criteria were reviewed. Of the 284 infants, 134 were in group 1 and 150 infants were in group 2. There were no significant statistical differences between group 1 and group 2 in neonatal and maternal demographic data and clinical data. Of 134 infants who received probiotics and lactoferrin, 11 developed NEC, while 26 of the 150 infants in group 2 developed NEC, and the difference was statistically significant (p = 0.023). Conclusion Probiotics and lactoferrin given orally to very low birth weight preterm infants were associated with a decreased rate of NEC.

Decisions and outcome for infants born near the limit of viability.

BACKGROUND: Initiation or withholding life support at birth on infants born prematurely near the limit of viability is not an easy decision, with wide variation in practice around the world. Our aim was to review the outcome of preterm infants born near the limit of viability at 23-25 weeks gestation in our institution, with regard to resuscitation decision, survival, and major outcome measures. METHODS: We included all live newborn infants born prematurely at 23-25 weeks gestation at King Faisal Specialist Hospital and Research Centre from January 2006 to December 2015. We collected data on resuscitation decisions, survival, and major neonatal morbidities such as severe brain injury, severe retinopathy of prematurity, and bronchopulmonary dysplasia. RESULTS: Between January 1, 2006 and December 31, 2015, 97 infants with a gestational age (GA) of 23-25 weeks gestation were admitted; 23, 42, and 32 infants were born at 23, 24, and 25 weeks gestation, respectively. At 23 weeks gestation, full support was initiated in 87% of patients and later on support was withheld in 17.4% of patients, finally 13% of patients survived to discharge. At 24 weeks, full support was initiated in 97.6% of patients, then withheld in 7.1% of patients, and ultimately 59.5% survived. At 25 weeks, full support was initiated in 93.8% of patients, then withheld in 15.6% of patients, and ultimately 62.5% survived. In terms of survival with and without the three major neonatal morbidities, at 23 weeks gestation, no infant survived without any morbidity as compared to 7.1% and 28.1% at 24 and 25 weeks, respectively. The incidence of survival with 1 major morbidity was 8.7%, 30.9%, and 34.4% at 23, 24, and 25 weeks, respectively, the incidence of survival with 2 major morbidities was 0%, 19%, and 0% at 23, 24, and 25 weeks, respectively, and the incidence of survival with 3 major morbidities was 4.3%, 2.4%, and 0% at 23, 24, and 25 weeks, respectively. CONCLUSION: In our patient cohort, survival and survival without major neonatal morbidity were very low at 23 weeks gestation, but it improved gradually as gestational age advanced.

Communication skills in pediatric training program: National-based survey of residents' perspectives in Saudi Arabia.

BACKGROUND: Good communication skills and rapport building are considered the cardinal tools for developing a patient-doctor relationship. A positive, healthy competition among different health care organizations in Saudi Arabia underlines an ever increasing emphasis on effective patient-doctor relationship. Despite the numerous guidelines provided and programs available, there is a significant variation in the acceptance and approach to the use of this important tool among pediatric residents in this part of the world. OBJECTIVE: To determine pediatric residents' attitude toward communication skills, their perception of important communication skills, and their confidence in the use of their communication skills in the performance of their primary duties. MATERIALS AND METHODS: A cross-sectional study was conducted among all pediatrics trainee residents working in 13 different hospitals in Saudi Arabia. A standardized self-administered questionnaire developed by the Harvard Medical School was used. RESULTS: A total of 297 residents out of all trainees in these centers participated in the data collection. The 283 (95%) residents considered learning communication skills a priority in establishing a good patient-doctor relationship. Thirty four percent reported being very confident with regard to their communication skills. Few residents had the skills, and the confidence to communicate with children with serious diseases, discuss end-of-life issues, and deal with difficult patients and parents. CONCLUSION: Pediatric residents perceive the importance of communication skills and competencies as crucial components in their training. A proper comprehensive communication skills training should be incorporated into the pediatric resident training curriculum.

Guidelines for palivizumab prophylaxis in infants and young children at increased risk for respiratory syncytial virus infection in Saudi Arabia.

Respiratory syncytial virus (RSV) is a leading cause of serious seasonal lower respiratory tract infections (LRTI) in high-risk infants and children, with epidemics occurring annually in Saudi Arabia from October to March. Premature infants born at less than 29 weeks gestation with chronic lung disease or those with significant congenital heart disease who have RSV infection are more likely to be hospitalized and have increased morbidity and mortality. Palivizumab (Synagis®, Medimmune) is a humanized monoclonal antibody for the prevention of severe LRTI by RSV in high-risk children. The current use of Palivizumab in Saudi Arabia is not regulated and does not meet approved standards. This clinical practice policy statement was developed by the Ministry of Health and is supported by the National Immunization Technical Advisory Group (NITAG) in Saudi Arabia. It is based on available national and international data on the use of Palivizumab for the prevention of severe LRTI caused by RSV in high-risk pediatric patients. These guidelines were solicited and endorsed by two Saudi societies: The Neonatology and the Pediatric Infectious Diseases Societies.

Safety and pharmacokinetics of extended use of palivizumab in Saudi Arabian infants and children.

BACKGROUND: The peak season of respiratory syncytial virus (RSV) infections in warmer climates may extend beyond the typical five-month RSV season of temperate regions. Additional monthly doses of palivizumab may be necessary in warmer regions to protect children at high risk for serious infection by the RSV. METHODS: In a Phase II, single-arm, single-center, non-comparative, open-label, prospective study conducted in Saudi Arabia, children at high risk for RSV infection received up to seven monthly injections of palivizumab (15 mg/kg) during the 2000-2001 RSV season. Key enrollment criteria were no previous exposure to palivizumab and gestational age ≤35 weeks, ≤6 months of age at enrollment, or chronic lung disease and ≤24 months of age at enrollment. We wished to assess the safety, immunogenicity, and pharmacokinetics of palivizumab as an extended seven-dose regimen. RESULTS: Of 18 enrolled patients, 17 patients received seven palivizumab injections. Seven adverse events (AEs) occurred in five patients. Bronchiolitis was the most commonly reported AE. Six serious AEs occurred in four patients. No AEs were considered related to palivizumab. Trough levels of palivizumab in serum were >40 µg/mL in most patients after the first injection and in 16/18 and 14/17 patients after the fourth and sixth injections, respectively. Except for one patient at one visit, the anti-palivizumab titer was <1:10 at all visits. CONCLUSION: These data suggest that an extended palivizumab regimen of up to seven monthly doses during the RSV season exhibited an acceptable safety profile in children at high risk for RSV infection in Saudi Arabia.

Aborting a Malformed Fetus: A Debatable Issue in Saudi Arabia: Retraction.

[This retracts the article on p. 6 in vol. 1, PMID: 24027674.].

A Randomized Controlled Trial to Compare Heated Humidified High-Flow Nasal Cannulae with Nasal Continuous Positive Airway Pressure Postextubation in Premature Infants: Retraction.

[This retracts the article on p. 75 in vol. 2, PMID: 24049748.].

Aborting a malformed fetus: a debatable issue in saudi arabia.

Congenital anomalies contribute a significant proportion of infant morbidity and mortality, as well as fetal mortality. They are generally grouped into three major categories: structural/metabolic, congenital infections, and other conditions. The most prevalent conditions include congenital heart defects, orofacial clefts, Down syndrome, and neural tube defects. Several prenatal diagnostic procedures have been introduced, both cytogenetic (such as chorion biopsy, amniocentesis and funiculocentesis) and biophysical (ultrasound 2-D, 3-D and 4-D, ultrasonography with Doppler, etc.). Insufficient data are currently available from Saudi Arabia on the epidemiology of the lethal congenital abnormalities which should be a priority due to high rate of consanguineous marriages among first cousins and their association with congenital anomalies. In terms of consanguinity and birth defects, a significant positive association has been consistently demonstrated between consanguinity and morbidity, and congenital defects with a complex etiology appear to be both more prevalent in consanguineous families and have a greater likelihood of recurrence. A debate regarding aborting a malformed fetus still exists among the senior Islamic scholars in many of the Islamic countries. The progressive interpretations of Islam have resulted in laws allowing for early abortion on request in two countries; six others permit abortion on health grounds and three more also allow abortion in cases of rape or fetal impairment. In Saudi Arabia, efforts to legalize abortion in certain circumstances have been recently discussed among Senior Religious Scholars and specialized physicians to permit abortions in certain circumstances. In this mini-review we discuss the current debate regarding aborting a malformed fetus in Saudi Arabia with a focus on the Islamic perspective.

Short-term outcome of very low-birth-weight infants in a tertiary care hospital in Saudi Arabia.

BACKGROUND AND OBJECTIVE: Published data on short-term outcomes of very low birth weight infants from Saudi Arabia are limited. In the present study, our objective was to describe and analyze the outcomes of very low birth weight infants admitted to our neonatal intensive care unit and to compare the results with data published by the National Institute of Child Health and Development. DESIGN AND SETTING: This study was a retrospective analysis of prospectively collected data from a single tertiary care center over a three years period. PATIENTS AND METHODS: Biodemographic data and data regarding multiple outcome measures were analyzed for infants with birth weight of 1500 g or less. Data were obtained from our neonatal intensive care unit database. RESULTS: Our results included a total of 186 infants with birth weights of 1500 g or less. Of these infants, 154 (82.8%) survived to discharge. Seventy-six (40.9%) were male, and mean (SD) gestational age (GA) was 29 (2.9) weeks with a range of 21 weeks, 6 days to 36 weeks, 2 days. Mean (SD) birth weight was 1062 (302) g with a range of 420 to 1495 g. Fifty-seven (30.6%) infants were characterized as small for gestational age. Antenatal steroids were given to 74.2% of mothers. Eighty-five percent of infants were born by cesarean section. The rate of bronchopulmonary dysplasia was 17.7%, patent ductus arteriosus 31.2%, intraventricular hemorrhage 12.9%, periventricular leukomalacia 3.8%, necrotizing enterocolitis 7.5%, retinopathy of prematurity 28.3%, and late-onset sepsis was 21.9%. CONCLUSION: In this population of very low birth weight infants, survival rates and complications of prematurity were comparable to international data.

A decision aid for considering indomethacin prophylaxis vs. symptomatic treatment of PDA for extreme low birth weight infants.

BACKGROUND: Decision Aids (DA) are well established in various fields of medicine. It can improve the quality of decision-making and reduce decisional conflict. In neonatal care, and due to scientific equipoise, neonatologists caring for extreme low birth weight (ELBW) infants are in need to elicit parents' preferences with regard to the use of indomethacin therapy in ELBW infants. We aimed to develop a DA that elicits parents' preferences with regard to indomethacin therapy in ELBW infants. METHODS: We developed a DA for the use of the indomethacin therapy in ELBW infants according to the Ottawa Decision Support Framework. The development process involved parents, neonatologists, DA developers and decision making experts. A pilot testing with healthy volunteers was conducted through an evaluation questionnaire, a knowledge scale, and a validated decisional conflict scale. RESULTS: The DA is a computer-based interactive tool. In the first part, the DA provides information about patent ductus arteriosus (PDA) as a disease, the different treatment options, and the benefits and downsides of using indomethacin therapy in preterm infants. In the second part, it coaches the parent in the decision making process through clarifying values and preferences. Volunteers rated 10 out of 13 items of the DA positively and showed significant improvement on both the knowledge scale (p = 0.008) and the decisional conflict scale (p = 0.008). CONCLUSION: We have developed a computer based DA to assess parental preferences with regard to indomethacin therapy in preterm infants. Future research will involve measurement of parental preferences to guide and augment the clinical decisions in current neonatal practice.

The need for hospital-based neonatal palliative care programs in Saudi Arabia.

The terms palliative care, supportive care, and comfort care are used to describe individualized care that can provide a dying person the best quality of life until the end. The term "end-of-life care" is also used in a general sense to refer to all aspects of care of a patient with a potentially fatal condition. While the concept of palliative care is not new, it has only recently been applied to the neonatal population. To the best of our knowledge, none of the neonatal intensive care units (NICUs) in Saudi Arabia have adopted a neonatal program for palliative care. We believe the main reason is lack of knowledge of such programs and the fear of being accused of being heartless and cruel by providing comfort care for dying babies. Comfort care begins with the diagnosis of a life-threatening/terminal condition, and continues throughout the course of illness regardless of the outcome. In this perspective, our aim is to introduce these programs for caregivers in the NICUs in Saudi Arabia. For this purpose, we have reviewed the current recommendations in establishing neonatal palliative care programs and discussed some of the social and religious aspects pertaining to this issue.

Urinary bladder perforation in a very low birth weight infant. A case report.

Perforation of the urinary bladder is a rare complication with a considerable degree of morbidity and mortality in modern neonatal intensive care units. We report a case of urinary bladder perforation, which probably was triggered by prolonged urinary retention secondary to morphine infusion, using credé maneuver on an already over-distended bladder, and inserting an umbilical catheter as urethral catheterization in an extremely low birth weight infant.