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Preterm Birth Complication clinical trials

View clinical trials related to Preterm Birth Complication.

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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: NCT06262308 Not yet recruiting - Clinical trials for Preterm Birth Complication

Emotional Support for Women Experiencing PPROM

Start date: March 2024
Phase: N/A
Study type: Interventional

Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women.

NCT ID: NCT06110481 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Reversibility of Bronchial Obstruction in Children Born Preterm

Start date: April 1, 2021
Phase:
Study type: Observational

This observational study aims to compare responses to different, commonly used inhaled bronchodilators in children born preterm with bronchial obstruction at spirometry. All children were diagnosed with Chronic Lung Disease of Immaturity (CLDI). The main questions are: - Is any inhaled bronchodilator or their combination generally superior in children with CLDI when assessing the reversibility of bronchial obstruction? - Is there an individual difference in the effect of betamimetic, anticholinergic or their combination between children with CLDI? Participants will: - Come to our clinic in a stable state without acute infection and they will be randomly assigned to the first inhaled bronchodilator. - They will then perform a spirometry test before and after the inhalation of the drug. - This visit will repeat 3 times, each with a different bronchodilator (beta2agonist, anticholinergic and their combination).

NCT ID: NCT06074601 Active, not recruiting - Preterm Birth Clinical Trials

MIRACLE of LIFE Study

MoL
Start date: August 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?

NCT ID: NCT06052865 Recruiting - Clinical trials for Preterm Birth Complication

Serial Brain MRI in Hospitalized Preterm Infants

Start date: September 14, 2020
Phase: N/A
Study type: Interventional

The purpose of this research study is to use serial magnetic resonance imaging (MRI) to define the timing and factors associated with brain injury as well as the pattern of brain growth of very preterm infants during hospitalization in the neonatal intensive care unit (NICU). In addition, the goal is to utilize early MRI to risk-stratify preterm infants and tailor rehabilitative interventions according to risk in order to explore associations between NICU rehabilitative intervention and short- and long-term outcomes of preterm infants.

NCT ID: NCT05955404 Completed - Clinical trials for Preterm Birth Complication

Kangroo Mother Care

Start date: November 2, 2022
Phase: N/A
Study type: Interventional

infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.

NCT ID: NCT05827679 Completed - Clinical trials for Digestive System Disease

Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature (ECAP)

ECAP
Start date: March 15, 2023
Phase:
Study type: Observational

Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, which is expressed by abdominal distension, regurgitation or vomiting, irregular transit and abdominal discomfort. This feeding intolerance influences the length of hospitalization and can lead to necrotising enterocolitis, a major complication. In the Neonatal Intensive Care Units of Clermont-Ferrand hospital center, abdominal massages have been performed by physiotherapists for several years in order to improve the condition of the digestive system. However, the indication for abdominal massage is very dependent on the caregivers in charge of the newborn and the evaluation of the abdominal condition remains subjective with a great variability between examiners. Thus, some newborns will receive massage multiple times a day while others will not. Developmental care is essential for these premature infants, especially to avoid over-stimulation. It is important not to add care, such as massage, if it is not needed. It is therefore essential to properly assess the digestive status of premature babies in order to determine whether they have feeding intolerance and whether they require treatment with abdominal massage. To date, the investigators have not found measurable criteria or existing scales that can describe the digestive status of newborns. The main objective of the study is therefore to create and validate a clinical assessment scale for the abdominal status of preterm infants.

NCT ID: NCT05624541 Recruiting - Cerebral Palsy Clinical Trials

Validity and Reliability of Specific Test of Early Infant Motor Performance (STEP) Version 3.0

Start date: January 18, 2022
Phase:
Study type: Observational

Cerebral palsy and other neuromotor disorders are more common in babies born preterm (<37 weeks of gestation), due to various biological and environmental risk factors and the risk increases as the gestational age decreases. Earlier and more frequent screening with the use of developmental skills tests facilitates referral to early intervention programs. Current guidelines recommend using some combination of neuroimaging and neurological examination and assessments such as neonatal imaging, general movements (GMs), and Hammersmith Infant Neurological Examination (HINE) for early diagnosis and intervention.

NCT ID: NCT05607706 Completed - Clinical trials for Stress Related Disorder

Effect of Maternal Odor and Kangaroo Care on Serum Cortisol and Comfort Levels in Preterm Infants: a Randomised Trial

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Aims and objectives: Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored. Background: They are exposed to different stressors. Too much stress will increase their problems in their future lives. Design: This study was planned as a randomized study to determine the effects of Kangaroo Care and mother scent application on toxic stress in preterm infants in the Neonatal Intensive Care Unit environment and to create evidence-based recommendations regarding these applications. Methods: Research data were collected from a total of 92 preterm babies born. Babies were divided into 3 groups, those who never met their mothers, only mother scent group and KC group. The mother's undershirt was used as the maternal odor. Vital signs, blood cortisol levels and Preterm Infant Comfort Scale scores were determined and recorded each group.The data were evaluated by statistical analysis. The CONSORT checklist for reporting qualitative research was used. Results: In the group that never encountered mother and mother odor, Preterm Infant Comfort Scale, blood cortisol level and vital signs showed severe stress. It was found that maternal odor is effective in reducing this stress, but kangaroo care is much more effective in preventing stress. Conclusion: if premature babies are deprived of their mother, the stress may be exposed to reaches toxic levels. It was determined that kangaroo care application during the treatment of these babies is a more effective method in reducing stress than the maternal odor application method. Relevance to clinical practice: The results of this study will contribute to nurses' use of kangaroo care and maternal odor in the care of preterm babies to prevent stress and related complications.Therefore, it will improve the quality of care of preterm babies in the NICU.

NCT ID: NCT05232994 Not yet recruiting - Preeclampsia Severe Clinical Trials

Metformin and Esomeprazole For Preterm Pre-eclampsia

Start date: March 1, 2023
Phase: Phase 1
Study type: Interventional

A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.