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Premature Birth clinical trials

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NCT ID: NCT06359015 Active, not recruiting - Preeclampsia Clinical Trials

Metformin and Esomeprazole in Preterm Pre-eclampsia

Start date: February 11, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia.

NCT ID: NCT06354517 Not yet recruiting - Pre-Term Clinical Trials

The Impact of the SENSE Program on NICU

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined.

NCT ID: NCT06353243 Recruiting - Preterm Birth Clinical Trials

Bilateral Infant Stimulation Study

BLISS
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.

NCT ID: NCT06352047 Completed - Premature Infants Clinical Trials

The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation. Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation. Hypothesis 0b (H0b): There is no difference between the respiratory rate of preterm infants in supine and prone positions after extubation. Hypothesis 0c (H0c): There is no difference between the respiratory rhythms of preterm infants in supine and prone positions after extubation. Hypothesis 0d (H0d): There is no difference between respiratory distress in preterm infants in supine and prone positions after extubation.

NCT ID: NCT06351202 Recruiting - Clinical trials for Digestive System Disease

Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms

PREMABDO
Start date: May 16, 2024
Phase: N/A
Study type: Interventional

Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication. At the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective. In this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively. The hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants. The aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days.

NCT ID: NCT06350565 Not yet recruiting - Clinical trials for Respiratory Distress Syndrome of Newborn

A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+)

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus.

NCT ID: NCT06349122 Not yet recruiting - Bacterial Vaginosis Clinical Trials

Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth

AUTOP2
Start date: August 2024
Phase: Phase 4
Study type: Interventional

Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis. The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth. The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.

NCT ID: NCT06348641 Not yet recruiting - Pain Clinical Trials

Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn. This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups. Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist. The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher. Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant. The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.

NCT ID: NCT06346236 Completed - Clinical trials for Transient Hypothyroxinemia of Prematurity

Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

NEO-TYR
Start date: March 1, 2020
Phase:
Study type: Observational

Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent. In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 < 12 pmol/L and a level of TSH < 15 mUI/L before 15 days of life or < 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.

NCT ID: NCT06345742 Recruiting - Preterm Clinical Trials

The Effect of Parental Participation on Newborn Comfort During Diaper Care

Start date: December 19, 2023
Phase: N/A
Study type: Interventional

It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants. H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort. H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants. H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.