Neonatal Complications

Researchers are evaluating how well symphysis fundal height SFH measurements alone compare to SFH combined with point of care ultrasound POC-US measuring fetal abdominal circumference AC for detecting small or large for gestational age infants among low-risk pregnant women after 35 weeks gestation. The study aims to improve prenatal identification of abnormal fetal growth, which is linked to risks for mother and baby. This open-label, randomized trial is investigator-sponsored and focuses on low-risk pregnancies managed by midwives. Participants are randomly assigned to one of two groups one group will have fetal growth monitored using SFH measurements alone, while the other will have SFH plus POC-US to measure fetal AC and assess amniotic fluid volume. Measurements occur at scheduled antenatal visits at 35-38, 40, 41, and beyond 41 weeks gestation. If screening suggests abnormal growth or amniotic fluid levels, a formal obstetric ultrasound by a specialist will be performed. All women will have POC-US at 41 and 41 weeks to check amniotic fluid, regardless of group. During the study, midwives will review medical histories, conduct physical measurements, and perform ultrasound assessments following the assigned method. Researchers will compare prenatal screening results to actual birth weights to identify small or large infants. They will also track the number of formal ultrasounds requested, cases of abnormal amniotic fluid, and maternal and neonatal outcomes. Participation lasts from enrollment at 35-38 weeks through delivery and initial postnatal assessment, about one year on average.

Researchers are evaluating a new hospital incubator pad that provides stochastic vibrotactile stimulation SVS as a complementary treatment for apnea of prematurity AOP, a common condition in preterm infants where breathing stops for 20 seconds or more. This study aims to establish the safety, effectiveness, and clinical risks and benefits of this device, which could improve management of AOP beyond the current standard therapy of caffeine citrate. The study focuses on newborns born before 33 weeks gestational age and younger than 38 weeks postmenstrual age at enrollment. The study compares two groups one receiving standard therapy with caffeine citrate plus continuous SVS stimulation via the Prapela SVS incubator pad, and a control group receiving standard therapy with an inert pad that looks identical but does not vibrate. Treatment with the SVS pad continues until the infant is apnea-free for three days and less than two weeks from anticipated discharge, or until the clinician decides to stop. If apnea returns after stopping, treatment may be restarted. Follow-up surveys will be conducted by telephone at 1 and 2 years of age to assess neurological development. Participants will be monitored closely with clinical evaluations and questionnaires completed by clinicians to assess risks and benefits. The primary outcome is the change in apnea rate during 7 to 28 days of intervention, with secondary outcomes assessed at earlier time points. The study is randomized and single-masked, with safety and efficacy data gathered to support possible FDA clearance and future use of the SVS incubator pad as an adjunctive therapy to improve outcomes in preterm infants with AOP.

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low 30% or high 60% oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infants oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

Researchers are evaluating the maximum safe and tolerated dose of Levetiracetam LEV for treating neonatal seizures. This Phase IIb, open-label dose-escalation study aims to determine if higher doses of LEV than currently used can improve seizure control in newborns. The study includes infants at risk or confirmed to have neonatal seizures of mild to moderate severity, with continuous video EEG monitoring used to assess seizure activity and control. Participants initially receive a 60 mgkg dose of LEV. If seizures persist after this dose, they are randomized to either receive higher doses of LEV 90 mgkg, 120 mgkg, or 180 mgkg in increments or treatment with Phenobarbital PHB at 20-40 mgkg. Maintenance treatment with PHB may continue for five days either intravenously or orally if tolerated. The study includes three phases, with Phase 3 expanding to neonates with more severe seizure burden if earlier phases show efficacy. Throughout the study, participants are monitored with continuous EEG reviewed by neurophysiologists to assess seizure control over 24 hours and changes in seizure burden during the two hours after treatment. Safety, pharmacokinetics, seizure freedom rates, adverse events, and long-term outcomes up to eight years are evaluated. The study also assesses new technology for neonatal seizure detection. Participation may last several years due to extended follow-up for long-term outcomes.

Researchers are conducting a nationwide, multicenter observational study in China to investigate the severity and challenges faced by Small Vulnerable Newborns SVN, including preterm, small for gestational age, and low birth weight infants. The study aims to provide a clear and unified description of these newborns issues and to develop targeted prevention strategies to improve care and outcomes. This comprehensive research gathers data across multiple centers to better understand the scope of these conditions. In this study, participating hospitals across China will collect clinical data on vulnerable newborns under their care throughout 2024. Detailed questionnaires will be completed to support thorough data collection. The study does not involve any treatment interventions instead, it focuses on observation and data gathering to assess the incidence, complications, and mortality rates of these newborns. Participants in the study will have their clinical information recorded from hospital admission until discharge or death, with follow-up up to one year. Researchers will measure the number of small vulnerable newborns, their mortality rates, and the incidence of related complications. This observational approach aims to provide valuable insights to guide prevention efforts and improve care for these at-risk infants.

Researchers are exploring how giving pregnant individuals a choice among different nutrition and exercise programs affects their ability to stick to the program and maintain healthy pregnancy outcomes. The study focuses on preventing excessive gestational weight gain by comparing adherence to three lifestyle intervention strategies within the Nutrition and Exercise Lifestyle Intervention Program NELIP. This research uses a pseudo-randomized design to examine if choice improves participation compared to no choice in pregnant individuals between 12 and 18 weeks of pregnancy with a single fetus. Participants are divided into two groups one group chooses from three intervention strategies and the other group is matched to a choice participant and receives the same strategy without choice. The three strategies vary in timing of introducing nutrition and exercise components either both simultaneously starting at 12-18 weeks, or nutrition first followed by exercise at 25 weeks, or exercise first followed by nutrition at 25 weeks. The exercise involves a supervised walking program with gradually increasing duration, and nutrition is based on a modified gestational diabetic meal plan tailored per participant. The full program continues until delivery, with final intervention measures between 34 and 36 weeks gestation. Participants will be monitored weekly for adherence using a point system, with additional assessments of satisfaction and health outcomes like weight gain, birth measurements, and pregnancy complications. Follow-up visits occur at birth and at 2, 6, and 12 months postpartum to track maternal and infant health. The study collects detailed data on nutrition, exercise, and pregnancy progress to understand how choice impacts adherence and outcomes over this extended timeline.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of AOC 1044, also known as delpacibart zotadirsen, for treating Duchenne Muscular Dystrophy DMD in boys aged 7 to 16 with specific gene mutations suitable for exon 44 skipping. This study is designed as a randomized, double-blind, placebo-controlled trial to assess the impact of this intravenous treatment on muscle function over time. Participants will be randomly assigned to receive either AOC 1044 or a placebo infusion every 6 weeks for 54 weeks, totaling 9 doses during the double-blind treatment period. After this, all participants can join an open-label extension where they receive AOC 1044 every 6 weeks for another 54 weeks, adding 9 more doses. Following the final dose at week 102, participants will have assessments at weeks 108 and 114 to evaluate safety and treatment effects. During the study, participants will undergo various assessments including tests for time to rise velocity, muscle strength, walking and climbing abilities, and quality of life measures. Muscle enzyme levels and global impressions of severity and change from both patients and caregivers will also be monitored. Safety and tolerability will be reviewed regularly by an independent committee. Overall participation lasts over two years, including screening, treatment, extension, and follow-up phases.

Researchers are studying HLX3901 in an open-label, first-in-human phase I clinical trial involving patients with advanced small cell lung cancer SCLC or neuroendocrine carcinoma NEC. The study aims to evaluate the safety, tolerability, and how the drug behaves in the body, focusing on patients who have experienced intolerance, recurrence, or disease progression after prior treatments. The study has two parts Phase Ia uses dose escalation and backfill cohorts where patients receive HLX3901 via intravenous infusion at increasing doses, observing dose-limiting toxicities over 4 weeks. Phase Ib expands the dose to confirm safety and efficacy of HLX3901 monotherapy in selected groups based on Phase Ia data. Participants receive the recommended Phase 2 dose RP2D identified during dose escalation. Participants will undergo screening, treatment cycles of 4 weeks, and monitoring of side effects and tumor response using objective response rates and survival measures over approximately 24 months. Safety reviews guide dosing decisions, and tumor tissue will be collected to test for DLL3 expression. The study involves regular assessments including laboratory tests and imaging to monitor health and treatment effects throughout participation, which can last up to about two years.

Many premature newborns have trouble breathing after birth and receive support with a breathing machine called nasal continuous positive airway pressure NCPAP. When their breathing worsens despite NCPAP, they may be treated with surfactant medication inserted into the windpipe using either a ventilation tube or a thin catheter. This research is studying the use of video laryngoscopes, which have a camera and display the airway on a screen, compared to standard direct laryngoscopes that require doctors to look directly into the babys mouth to insert the tube or catheter. The study aims to see if video laryngoscopy improves the success rate of inserting the thin catheter on the first attempt without causing drops in oxygen or heart rate. The study observes infants who need a thin endotracheal catheter inserted for surfactant administration. It compares two approaches using a video laryngoscope versus a direct laryngoscope during the insertion. This is done across multiple hospitals, each switching from direct to video laryngoscopy over time. The study does not assign which method is used but records which laryngoscope was used for each insertion attempt to compare outcomes. The main focus is on successful first attempts without physiologic instability, as well as secondary measures like number of attempts, duration, oxygen levels, heart rate, and any complications. Participants are newborn infants up to 28 days old who require thin catheter insertion for surfactant treatment and whose parents have consented to share data. Researchers will collect detailed information during and after the insertion attempt, including heart rate, oxygen saturation, duration of the procedure, and any adverse events such as oral trauma or need for chest compressions. Data will be analyzed to evaluate the success and safety of using video versus direct laryngoscopy. The total participation time depends on when the catheter insertion is performed and the follow-up assessments within 72 hours after the procedure.

Researchers are studying the use of two new surgical devices, the Karl Storz Curved and Straight Fetoscopes, to assist in minimally invasive in-utero surgeries. These devices help surgeons see inside the uterus during procedures to treat fetal conditions like twin-twin transfusion syndrome and other complex anomalies. The study aims to assess surgical outcomes, complications, and gestational age in patients treated with these scopes, helping to understand their potential benefits in fetal surgery. The curved fetoscope is designed for patients with an anterior placenta, while the straight fetoscope is used for those with a posterior placenta. Both scopes assist in fetoscopic laser photocoagulation, a procedure that seals abnormal blood vessels in the placenta using laser energy. This research is a non-randomized, single arm study where eligible patients undergo intrauterine procedures with either the curved or straight scopes based on placenta position. The study will collect data on the success of the procedures and related complications for descriptive analysis. Participants will be monitored through the procedure and follow-up until birth and shortly after. The study will evaluate outcomes such as the rate of completed fetoscopic procedures, fetal survival at birth, and various maternal and fetal complications. Researchers will also track gestational age at delivery, procedure length, and short-term neonatal health. The total study duration extends over several years to capture both immediate and longer-term results of using these devices in fetal surgery.