Neonatal Intensive Care Unit

6

Review clinical trials related to Neonatal Intensive Care Unit. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

NICU-to-Home Dyadic Support for Very Preterm Infants and Families

This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families. Parent-preterm infant dyads will be assigned to homebased SPEEDI, telehealth SPEEDI, or a control group. SPEEDI is an early developmental intervention focused on supporting parent confidence, interpretation of infant behavioral cues, and parent-infant relationship building through developmentally appropriate play. The study will assess feasibility of initiating SPEEDI 1 to 5 days after NICU discharge, including recruitment, retention, session attendance, activity log completion, intervention adherence, and delivery differences between homebased and telehealth SPEEDI. Family experiences and provider perspectives on strengths and barriers to SPEEDI implementation will also be evaluated.

Participants needed: 40
Trial details
Age: 0-6Biological sex: AllType: InterventionalSponsor: University of MinnesotaUpdated: Oct 9, 2026Locations: 2
Eligibility criteria

Written informed consent obtained from participant and ability for participant t... [+8]

Infant has a genetic syndrome or metabolic disorder known to be progressive or t... [+8]

Status: Not yet recruiting

ACT-Based Counseling to Improve Psychological Flexibility in Mothers of Infants Hospitalized in the NICU

This randomized controlled trial will evaluate two Acceptance and Commitment Therapy (ACT)-based counseling approaches for mothers whose infants are hospitalized in a Neonatal Intensive Care Unit (NICU). Mothers of infants in the NICU may experience high levels of stress, anxiety, and depressive symptoms. ACT is an approach that aims to improve psychological flexibility by helping people respond more effectively to difficult thoughts, emotions, and stressful experiences. A total of 135 mothers will be enrolled from two hospitals in Istanbul, Türkiye. Participants will be randomly assigned to one of three groups: an individual online ACT-based workshop, an ACT-based chatbot counseling program, or standard care. Mothers in the online workshop group will receive one individual 60-minute online session that includes mindfulness, acceptance, cognitive defusion, values clarification, and committed action exercises. Mothers in the chatbot group will receive ACT-based psychoeducation, guided exercises, and supportive digital counseling through a mobile application for four weeks. Mothers in the control group will receive the routine information and care normally provided in the NICU. Psychological flexibility will be the primary outcome. Depression, anxiety, and stress symptoms will be evaluated as secondary outcomes. Assessments will be completed at baseline, Week 2, Week 4, and at the 6-month follow-up. The study aims to determine whether ACT-based online and digital counseling can improve psychological flexibility and reduce psychological distress among mothers of infants hospitalized in the NICU.

Participants needed: 135
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Meserret AslanUpdated: Sep 23, 2026
Eligibility criteria

Not listed

Status: Recruiting

The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns

Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications. This randomized controlled trial evaluates the impact of Gentle Human Touch (GHT) and rate change (eye mask and earplug) on pain and comfort during heel prick blood collection in premature infants (32-36+6 weeks gestational age). A total of 60 infants were randomly assigned to three groups: GHT, rate change, and standard care (pacifier). Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R), and comfort was measured before, during, and after the procedure using the COMFORTneo operator. Physiological impact (heart rate, oxygen saturation) and propagation time were recorded. The findings provide evidence for safe and effective non-pharmacological interventions in pain management and their inclusion in developmental care protocols.

Participants needed: 60
Trial details
Age: 32-37Biological sex: AllType: InterventionalSponsor: Kubra Nur Kabakcı SarıdağUpdated: Sep 16, 2026Locations: 1
Eligibility criteria

Preterm infants with a gestational age between 32 and 36+6 weeks [+1]

Infants with serious medical conditions that may affect study parameters [+1]

Status: Recruiting

Pasteurised Donor Human Milk Supplementation for Term Babies

PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.

Participants needed: 1,444
Trial details
Phase: Phase 4Age: 0-48Biological sex: AllType: InterventionalSponsor: The University of QueenslandUpdated: Sep 2, 2026Locations: 4
Eligibility criteria

Mother is >18 years at the time of consent [+5]

Multiple pregnancy [+5]

Status: Not yet recruiting

Maternal Sensory Interventions in Newborns

This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.

Participants needed: 80
Trial details
Age: 35-42Biological sex: AllType: InterventionalSponsor: Kirsehir Ahi Evran UniversitesiUpdated: Jul 27, 2026Locations: 1
Eligibility criteria

Gestational age between 35 and 42 completed weeks. [+5]

Five-minute Apgar score <4. [+7]

Status: Recruiting

Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

The detection and appropriate treatment of seizures significantly impact the neurological prognosis of patients in intensive care. Indeed, altered brain function including seizures is described in critically ill children, regardless of the reason for admission. Most seizures are subclinical and therefore impossible to diagnose without neuromonitoring tools. Despite being concidered ad Gold Standard, continuous EEG (cEEG) with video recording shows difficulty of implementation and interpretation at all hours of the day and night explaining that less than 10% of centers in France use cEEG routinely. Most departments prefer simplified techniques, including amplitude traces (aEEG) which can be used continuously at the bedside. However, the positive predictive value of aEEG in the detection of seizures does not exceed 78% and 64% in newborns and children respectively making necessary an optimization of the information provided by these techniques. This project is a pragmatic diagnostic study that aims at developing and evaluating a neuromonitoring interface adapted to the needs of pediatric and neonatal intensive care units and meeting the requirements of neurophysiologists in terms of EEG trace quality.

Participants needed: 120
Trial details
Age: Up to 24Biological sex: AllType: ObservationalSponsor: Nantes University HospitalUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

Patients younger than 2 years old hospitalized in the intensive care unit with a... [+2]

Parents who do not understand French. [+2]