Active clinical trials for "Premature Birth"

Citicoline as neuroprotector in preterm

Preterm infants (gestational age between 189 and 258 days) with a birth weight (BW) greater than 1250 grams will be randomized to personalized-parenteral nutrition (P-PN) or standardized-parenteral nutrition (S-PN). The aim of the study is to evaluate the effect of S-PN versus P-PN on growth of preterm infants with BW>1250 grams.

Comparing the cardio-respiratory adaptation and differences to non invasive ventilation techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs synchronized (SNIPPV) in preterm newborns (gestational age at birth < 32 weeks) at their first approach to non invasive ventilation as first intention (soon after birth) or after extubation.

This study is a non-blinded, prospective, randomized controlled trial designed to compare the effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of time (days) that pregnancy continues after a patient's water bag has ruptured prematurely. If a patient has been diagnosed with rupture of their water bag between 18 0/7 weeks and 22 6/7 weeks and there are no other associated complications with the pregnancy, the patient is eligible for initial consideration for this study. Patients will be admitted to the hospital for a 24-hour monitoring period. If the patient remains without further complications during this monitoring period, the patient will be eligible for enrollment. If enrollment is desired, the patient will be randomly assigned to receive either antibiotics (treatment arm of the study) or no antibiotics (control arm of the study). The treatment arm will receive an outpatient, 7-day course of oral antibiotics (azithromycin and amoxicillin) with the first dose given in the hospital to ensure no side effects. The control arm will not receive outpatient antibiotics. Both groups will have weekly, office follow-up visits with high-risk pregnancy specialists to ensure no further complications. Both groups will be admitted to the hospital if the patients reach 23 0/7 weeks without complications. At this time the patients will receive all medications and therapies recommended by the governing board of OBGYNs. Subjects of both groups will also be admitted before 23 0/7 weeks if further complications noted either at their clinic follow up visits or anytime outside of the hospital. The duration of time that the patient remains pregnant after breaking of the water bag will be compared in each group. The investigators will also see if there is a difference in the number of patients able to reach 23 0/7 weeks between each group (treatment versus control).

The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food and (2) a novel cognitive behavioral therapy intervention in undernourished Sierra Leonean women. The main questions it aims to answer are: Will the addition of omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as choline, to a maternal ready-to-use supplementary food (M-RUSF+) prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (M-RUSF)? Will M-RUSF+ improve infant cognitive development at 9 months of age when compared with M-RUSF? Will the novel CBT program improve ante- and post-partum depression?

The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age. The main question it aims to answer is: What is the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age? Participants will be randomly assigned to the intervention (cerclage) or comparison (no cerclage) group.

Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin holding (SSH) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSH; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSH; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff. The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 3 continuous weeks is proposed. 20 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 3 continuous weeks, or to 3 weeks of standard NICU care. Research questions: Is it feasible to enrol 20 infants, complete a 3-week treatment period, and have complete data of growth measure outcomes in 17 preterm infants in the NICU in a pilot RCT of daily Calmer treatment versus standard care to inform a larger, definitive RCT? Are there differences in brain oxygen signalling, physical growth markers (e.g. daily weight gain) between groups measured at start of the study and after 3 weeks of daily Calmer exposure?

Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.

The aim of this study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.

Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.