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Breastfeeding clinical trials

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NCT ID: NCT02399774 Not yet recruiting - Breastfeeding Clinical Trials

Dental Support Device During Breastfeeding as a Mean for Pain Control

Start date: May 2015
Phase: Phase 3
Study type: Interventional

Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one. This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

NCT ID: NCT02349464 Completed - Breastfeeding Clinical Trials

Promoting Lactation Education, Access, and Support Efforts for Preterm Infants

PLEASE
Start date: December 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk.

NCT ID: NCT02317653 Completed - Pregnancy Clinical Trials

Understanding the Influence of Pregnancy on Breast Milk

Mom2Baby Pilot
Start date: February 2015
Phase:
Study type: Observational

The purpose of this study is to identify the influences of pregnancy on breast milk and the effects of these on the health of babies during the first 2 months of life. The investigators hypothesize that overweight and obese mothers will have lower serum n-3 to n-6 PUFA ratios during pregnancy and postpartum than normal weight mothers and will be positively correlated with TNF-α, IL-1β, resistin, and negatively correlated ghrelin levels both in serum and in breast milk in postpartum.

NCT ID: NCT02313181 Completed - Breastfeeding Clinical Trials

Early Limited Formula for Treating Lactation Concerns

ELF-TLC
Start date: January 7, 2015
Phase: N/A
Study type: Interventional

This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.

NCT ID: NCT02269462 Completed - HIV Clinical Trials

A Study to Evaluate the Effects of Genetic Factors on the Pharmacokinetics of Antiretroviral Drugs During Pregnancy and Lactation

Start date: December 2012
Phase: N/A
Study type: Observational

Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis (PEP). However, the pharmacokinetics of certain ARVs is associated with marked inter-individual variability. This variability has been associated with single nucleotide polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and transcriptional regulators. Pregnancy is also associated with additional changes in pharmacokinetics. The resulting sub-therapeutic or supra-therapeutic drug exposures may have serious consequences for virological control, MTCT, emergence of drug resistance, and toxicity. Foetal and infant exposure to maternal ARV during pregnancy and breastfeeding is believed to play a role in the prevention of mother-to-child transmission of HIV (PMTCT). However, such exposures may also result in toxicity. For example, efavirenz is contraindicated in children less than 3 years old or 10kg but transferred to breastfed babies through breast milk. On the other hand, double exposure to nevirapine from breast milk and PEP may also predispose breastfed infants to nevirapine-associated toxicity. In the proposed study, the influence of selected SNPs in certain drug disposition genes on the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as the level of infant exposure to both drugs through breast milk, will be studied. Mathematical models will be developed to predict potential dose optimisation strategies during pregnancy, and to predict infant exposure to maternal drugs through breast milk.

NCT ID: NCT02233439 Not yet recruiting - Breastfeeding Clinical Trials

Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues

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

The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.

NCT ID: NCT02221895 Completed - Pregnancy Clinical Trials

The Effect of Early Versus Traditional Follow-Up on Breastfeeding Rates at 6 Months

Start date: March 2014
Phase: N/A
Study type: Interventional

The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week) postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher rate of breastfeeding 6 months postpartum.

NCT ID: NCT02220413 Completed - Breastfeeding Clinical Trials

Predictors of Lactogenesis II

Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to investigate what proportion of obese women will have a self-reported delay in lactogenesis II ("breastmilk coming in") compared to women with a normal weight. We hypothesize that obese women will have an absolute 20% increase in delayed lactogenesis II. We will compare two group of women for delayed lactogenesis II, one group with obese women (BMI>30) and one group of women with a normal weight (BMI<30). The secondary objective is to assess what other factors influence the self-reported delayed lactogenesis II.

NCT ID: NCT02148237 Completed - Breastfeeding Clinical Trials

Increase Breastfeeding Duration Among Puerto Rican Mothers

BFCM
Start date: August 2014
Phase: N/A
Study type: Interventional

This study is to determine preliminary effects of home-based individual breastfeeding consultation with and without cash incentives to increase breastfeeding (BF) duration among low-income Puerto Rican mothers enrolled in a Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

NCT ID: NCT02133716 Completed - Pain Clinical Trials

Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm

LACTEET
Start date: October 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates. This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid. The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose. The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture. The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry. Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.