Breast Milk

4

Review clinical trials related to Breast Milk. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Breast-milk Enema Administration to Stimulate Passage of Meconium

Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications

Participants needed: 20
Trial details
Phase: Phase 1Age: 23-28Biological sex: AllType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: Jul 28, 2026Locations: 1
Eligibility criteria

Preterm infants born at >23 and <28 weeks' gestational age born at Atrium Health... [+3]

Infants with Necrotizing Enterocolitis (NEC) ≥ stage II [+5]

Status: Not yet recruiting

The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants

Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life. Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose. This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.

Participants needed: 96
Trial details
Age: 32-37Biological sex: AllType: InterventionalSponsor: Mersin UniversityUpdated: Jul 24, 2026Locations: 1
Eligibility criteria

Parental consent for the baby's participation in the study [+15]

Parental disapproval of infant's participation in the study [+14]

Status: Recruiting

The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight

This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding and body weight.

Participants needed: 54
Trial details
Age: 29-33Biological sex: AllType: InterventionalSponsor: Aydin Adnan Menderes UniversityUpdated: Jan 6, 2026Locations: 1
Eligibility criteria

Preterm infants with a postnatal age of 29-33 weeks, [+2]

Infants with major congenital anomalies (such as congenital heart disease, cleft... [+11]

Status: Not yet recruiting

Impact of Breast Milk miRNAs on the Infant Gut Microbiota

The first 1000 days of life are a critical period for future health. A healthy gut microbiota (GM) is essential for preventing both short-term and long-term health issues. Breast milk (BM) plays a key role in establishing the GM, as, unlike formula milk, it contains miRNAs that may interact with and modulate the microbiota. Primary Objective: To study the effect of BM on the composition of fecal miRNAs in exclusively breastfed infants compared to those fed with formula milk at different times (D10, D30, D60, M6, M12). Secondary Objectives: Analyze the effect of BM miRNAs on infant fecal microbiota, taking environmental confounding factors into account. Study the influence of BM microbiota on miRNA profiles in the milk. Examine the effect of BM microbiota on the infants' gut microbiota. Explore the links between BM miRNAs, infant gut microbiota, and intestinal inflammation.

Participants needed: 200
Trial details
Age: 18-50Biological sex: FemaleType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Oct 21, 2024Locations: 1
Eligibility criteria

Pregnant women in the 3rd trimester of pregnancy (3T) with a normal course of pr... [+8]

Cesarean delivery [+6]