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Prematurity clinical trials

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NCT ID: NCT03061890 Completed - Prematurity Clinical Trials

Developmental Impact of NICU Exposures (DINE)

DINE
Start date: April 1, 2017
Phase:
Study type: Observational [Patient Registry]

The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.

NCT ID: NCT02438267 Completed - Prematurity Clinical Trials

Preterm Infants and Nephrocalcinosis

NC
Start date: April 2015
Phase: N/A
Study type: Observational

Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born prematurely and with very low birth weight (<1500 gm) seem to be at the highest risk of developing NC. Recent changes in recommendations for nutrition for the preterm infant such as higher intakes of protein, calcium, and vitamin D may also play a factor in the pathogenesis of NC. Currently, diagnosis of NC often occurs incidentally during ultrasound evaluation for other issues. Because there is no acute symptom or pattern of symptoms in the preterm population associated specifically with NC, it is possible that many cases of NC may not be diagnosed. Presently, it is impractical and costly to screen all infants for NC with renal ultrasound, therefore there is no standard of care regarding screening for NC. NC may have long-term effects. Studies have shown that preterm infants with NC had shorter kidneys and a lower rate of tubule resorption of phosphorus (TRP) than preterm infants without NC. This study will analyze weekly urinalysis for all enrolled subjects prospectively and then look at the incidence of NC at discharge of the enrolled subjects.

NCT ID: NCT02273843 Completed - Prematurity Clinical Trials

A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis

Start date: September 2013
Phase: Phase 1
Study type: Interventional

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.

NCT ID: NCT02148965 Completed - Prematurity Clinical Trials

Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial

PAMELA
Start date: September 2014
Phase: N/A
Study type: Interventional

The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.

NCT ID: NCT02027584 Completed - Prematurity Clinical Trials

Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants

NEO-CHOLIN
Start date: November 2008
Phase: N/A
Study type: Observational

To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples

NCT ID: NCT01908907 Completed - Prematurity Clinical Trials

Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants

Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to understand if the "DHA gap" can be corrected by giving a daily dose of DHA oil to preterm babies. DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take it in through our diet. DHA is important for normal brain and eye health and it may also decrease inflammation. This is important for premature babies because they are at a greater risk for getting diseases related to inflammation, especially in their lungs, eyes and intestines. Since DHA is so important for normal growth, you will find DHA naturally in breast milk and it is now added to infant formula. But the amount in breast milk and infant formula is about half of what your infant should expect to get in the womb (about 13-29mg per day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even greater disadvantage because they cannot always eat very much right away and that is the only way they can get essential fatty acids in their body. This means premature babies are getting less DHA than they would in the womb and then the "DHA gap" continues for a longer period of time. This gap also comes at a time when their brain is growing most rapidly and their bodies need it the most. This trial is designed to see if giving DHA, even before the baby can take food orally, will raise his/her DHA blood levels to those of normal term babies.

NCT ID: NCT01908244 Completed - Prematurity Clinical Trials

Short-term Effects of Live Music in Preterm Infants

MTN05
Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.

NCT ID: NCT01852500 Completed - Prematurity Clinical Trials

Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy

Start date: November 2010
Phase: Phase 4
Study type: Interventional

Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants. The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.

NCT ID: NCT01800825 Completed - Pregnancy Clinical Trials

Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Preterm birth has been linked to certain types of vaginal infections. The goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)

NCT ID: NCT01787019 Completed - Prematurity Clinical Trials

Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age

Start date: January 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.