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Premature Birth clinical trials

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NCT ID: NCT03013023 Completed - Clinical trials for Parent-Child Relations

Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being

Start date: April 2015
Phase: N/A
Study type: Interventional

This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.

NCT ID: NCT03010891 Completed - Stress Clinical Trials

Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures

Start date: March 2016
Phase: N/A
Study type: Interventional

The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity. This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.

NCT ID: NCT03007186 Completed - PreTerm Birth Clinical Trials

Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus

Start date: October 2016
Phase:
Study type: Observational

This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.

NCT ID: NCT03007095 Completed - Preterm Children Clinical Trials

Preterm Birth and Social Cognition

TERM-COG
Start date: July 20, 2017
Phase: N/A
Study type: Interventional

The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.

NCT ID: NCT03005496 Completed - PreTerm Birth Clinical Trials

The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β

Start date: January 2017
Phase: Phase 4
Study type: Interventional

This study is a controlled trial which compares the effect of zinc, beta-carotene, and Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels in placenta.

NCT ID: NCT03001492 Recruiting - Clinical trials for Premature Progesterone Rise

Does Premature Luteinization Matter?

Start date: December 2016
Phase: N/A
Study type: Observational

Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.

NCT ID: NCT03001479 Completed - Clinical trials for Premature Birth of Newborn

Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein

Start date: March 13, 2017
Phase: N/A
Study type: Interventional

Breast milk is readily accepted as the ideal source of nutrition for almost all infants, including premature or very low birth weight infants. However, these high-risk infants require the addition of fortifiers to their milk in order to achieve sufficient levels of calories, vitamins, and minerals for adequate growth. We are currently using a liquid human milk fortifier which does not provide sufficient protein intake, requiring addition of a liquid protein supplement. A new product has been released which provides sufficient protein in the liquid HMF, without the acidification seen in previous products. This is a prospective, randomized noninferiority study comparing the safety and efficacy of the new HMF with additional protein to our current standard of adding additional protein supplementation on top of the HMF.

NCT ID: NCT02999061 Completed - PreTerm Birth Clinical Trials

Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition

Start date: December 2016
Phase: N/A
Study type: Observational

The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.

NCT ID: NCT02997345 Recruiting - Premature Birth Clinical Trials

PPROM Registry (Preterm Premature Rupture of Membranes)

Start date: July 2013
Phase:
Study type: Observational [Patient Registry]

Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.

NCT ID: NCT02996799 Recruiting - PreTerm Birth Clinical Trials

Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

Start date: January 2017
Phase: N/A
Study type: Interventional

For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.