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Premature Birth clinical trials

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NCT ID: NCT03689166 Completed - Preterm Birth Clinical Trials

Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth

PROPEV
Start date: October 23, 2017
Phase: N/A
Study type: Interventional

Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Shortening of the uterine cervix in early stages of gestation is a risk factor for PB. The presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for PB. However, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the PB in high-risk PB patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% PB risk before 34 weeks, and 50% PB prior to 37 weeks (> 6-10% PB). Similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.

NCT ID: NCT03689062 Not yet recruiting - Clinical trials for Premature Rupture of Membrane

Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

Start date: May 2019
Phase: N/A
Study type: Interventional

Prelabour rupture of membrane is defined as rupture of membranes prior to the onset of labour. Approximately 8% of pregnant women at term experience PROM, but the decision as to how term PROM should be managed clinically remains controversial, and there is wide variation in practice with no clear consensus on what constitutes optimal treatment. Although for the majority of women labour will start spontaneously within 24 hours following term PROM, up to 4%of women will not experience spontaneous onset of labour within seven days.

NCT ID: NCT03681782 Terminated - Premature Infant Clinical Trials

Evaluation of the Risks and Benefits of Abdominal Massage Treatment in Neonatalogy in Premature Children

PREMASS
Start date: March 15, 2018
Phase:
Study type: Observational

Premature birth creates difficulties for the child in starting his diet and digestion. The immaturity of the major vital functions complicates the abdominal transit. The initial diet, essentially parenteral in the central way, decreases progressively according to the digestive tolerance allowing the increase of the enteral feedings to optimize the growth. To ensure this transition, nurses nurses in Neonatology service, through their knowledge and expertise, practice a daily gesture: abdominal massage-care. This prevents or remedies a slowing of transit. The paramedical clinical examination of the child, determines the realization of this care. Several studies have proved the benefit of massage on the weight gain of premature babies. These stimulate peristalsis, decrease the duration of intestinal transit and the sensations of discomfort and pain related to it. Currently in Neonatology, developmental care (NIDCAP) is an approach to individualized care for the premature to improve its evolution. The fine observation of his behavior allows us to adapt our care and to ensure the respect of his pace. However, the first sensory capacity developed in the fetus, the touch can also be a source of over-stimulation for the premature baby. Moreover, the greater the prematurity, the greater the risk of occurrence of digestive complications. Can the abdominal care-massage in premature babies be harmful or risk increasing existing symptoms? The abdominal care-massage is neither described nor referenced in the nomenclature of nursing, neither taught nor subject to medical prescription. Few publications exist on this subject, no large-scale research has been reported. On the other hand, the perception of our empirical practice seems to show that the abdominal massage-care is an important aid to the smooth transit of the premature newborn. Transmitted orally by professionals to newcomers to Neonatology, this treatment is carried out in a heterogeneous manner according to professionals. Convinced of its effectiveness, carers wonder about their practice: is there an optimal technique without risk for the child? Determining the absence of risk and the effectiveness of the abdominal care-massage suggests a wider benefit for the well-being and progress of the premature child until he leaves the hospital. This validated practice could be disseminated on a larger scale in other neonatal departments.

NCT ID: NCT03680157 Completed - Premature Birth Clinical Trials

Comparing Rater Reliability of Familiar Practitioners to Blinded Coders

Start date: September 30, 2018
Phase:
Study type: Observational

The purpose of this study is to determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points. The investigator hypothesizes that the WECS will show external validity: that all coders will have high reliability on their WECS scores, despite exposure to the dyads' past videos by the clinical coders.

NCT ID: NCT03680001 Completed - Premature Birth Clinical Trials

Students Education Training in Emotional Connection

Start date: September 14, 2018
Phase:
Study type: Observational

The purpose of this study is to assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy. The investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the PI.

NCT ID: NCT03677908 Completed - Premature Birth Clinical Trials

Plasticity of Neonatal Neuronal Networks Temporal Theta Activity, the First Endogenous

NEURONAUX
Start date: July 1, 2016
Phase:
Study type: Observational

Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.

NCT ID: NCT03677752 Completed - Child Development Clinical Trials

GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial

GP_Posit
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the acceptability, feasibility and preliminary effects a GP_Posit intervention. GP_Posit is an intervention where mothers will learn how to participated in their preterm infant's care and positioning while being guided by a nurse. Preliminary effects will be estimated on maternal sensitivity, stress and anxiety as well as preterm infant's neurodevelopment.

NCT ID: NCT03675425 Active, not recruiting - Clinical trials for Patent Ductus Arteriosus After Premature Birth

The Effects of Phototherapy in Preterm Infants Pda

Start date: July 8, 2018
Phase: N/A
Study type: Interventional

The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.

NCT ID: NCT03675061 Completed - Pregnancy Preterm Clinical Trials

Evaluation of Vaginal PAMG-1 Detection by PartoSure Test in Preterm Delivery Threat in Actual Clinical Situation: Randomized Controlled Trial

PARTO-MAP
Start date: December 11, 2018
Phase: N/A
Study type: Interventional

Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great prematurity). More than half of these births follow spontaneous work. Before 34 weeks of amenorrhea, prematurity requires specific maternal-fetal management centered primarily on antenatal corticosteroid treatment for fetal maturation including 2 intramuscular injections at 24 hour intervals. This cure can only be done once and its benefit is proven in the 7 (to 14) days before the birth (recommendation for the clinical practice of the French National College of Obstetricians and Gynecologists of December 2016). The single course of antenatal corticosteroids before 34 weeks of amenorrhea is associated in the neonatal period with reduction in morbidity and mortality, and in the long term with an improvement of the survival without sequelae, if the full cure is administered in the 7, to 14, days before birth. The second key element of the management of a premature delivery threats is the admission in a pediatric structure adapted to the degree of prematurity. The care of a premature delivery threats before 34 weeks of amenorrhea care leads to hospitalization with possible transfer to a maternity of pediatric adapted level, tocolysis, a biological and bacteriological assessment, and, sometimes, other examinations and treatments. The prediction of premature labor is a challenge. Current methods, such as vaginal examination, cervicometry and detection of fetal fibronectin, make it possible to obtain a negative predictive value (NPV) approaching 100% but a poor positive predictive value (PPV), thus 8 out of 10 patients hospitalized and treated for premature delivery threat no not give birth within 7 days, or even before 34 weeks of amenorrhea. A better prediction of preterm delivery has two benefits: administer antenatal corticosteroid therapy in high-risk patients at the right time and not treat not-at risk patients. The PartoSure® test, which detects the placental protein vaginal alphamicroglobulin-1 (PAMG-1), has satisfactory metrological qualities according to observational studies : NPV 98% and PPV 75% of delivery within 7 days. However this test has never been evaluated in real clinical condition. In our study, the result of the test becomes decisional for the care. The hypothesis is that use of this test will improve the prediction of preterm delivery during a first consultation for preterm delivery threat and thus allow more frequent prenatal corticosteroid treatment in optimal period, avoiding treating non-at risk patients.

NCT ID: NCT03673709 Active, not recruiting - Premature Birth Clinical Trials

Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi

Start date: July 5, 2019
Phase: N/A
Study type: Interventional

In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care. We simultaneously identify the degree of implementation success and the contextual factors associated with success across 6 antenatal clinics in Blantyre District, Malawi. If results are negative, governments will avoid spending on ineffective care. Positive maternal, neonatal and HIV-related outcomes of group antenatal care will save lives, impact the cost and quality of antenatal care, and influence health policy as governments adopt this innovative model of care nationally.