Prematurity; Extreme

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

Condition / disease
Location
Status: Recruiting

Assessing Intellectual and Motor Outcomes in High-risk Infants

Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP. In this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre/ University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.

Participants needed: 600
Trial details
Age: 0-4Biological sex: AllType: ObservationalSponsor: University College CorkUpdated: May 13, 2026Locations: 4Duration: 30 Months
Eligibility criteria

Legal guardians must be able and willing to give written informed consent and to... [+3]

Death prior to discharge from the neonatal unit (High-Risk Infants only) [+1]

Status: Recruiting

Targeted Fortification of Donor Breast Milk in Preterm Infants

This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.

Participants needed: 50
Trial details
Age: 1-21Biological sex: AllType: InterventionalSponsor: Columbia UniversityUpdated: Apr 7, 2026Locations: 1
Eligibility criteria

Premature infants born </= 30 weeks gestational age [+1]

Parents do no consent to donor milk [+6]

Status: Recruiting

Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).

PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge. NEC is a serious bowel disease that can occur in premature babies, often requiring surgery and prolonged hospitalisation. This study runs alongside the WHEAT International Trial, which investigates whether pausing or continuing milk feeds during blood transfusions affects the risk of NEC in very preterm babies. PREM-IMPACT acts as a nested economic evaluation of the WHEAT Trial, helping to understand whether different feeding practices around transfusion offer good value for money from both the NHS and family perspective. PREM-IMPACT will collect detailed data on babies' health-related quality of life, as well as the financial, emotional, and social impact on parents and siblings. Families are recruited from neonatal units when their baby is ready to go home and complete questionnaires at three timepoints: 1) just before discharge, 2) six months later, and 3) twelve months later. Questionnaires cover health, wellbeing, healthcare use, and costs to the family (such as travel, time off work, or extra care needs). A dedicated research nurse based at the lead NHS site helps coordinate follow-up centrally. By studying families of babies with and without NEC, this project aims to clarify the burden of prematurity and NEC on infant outcomes and family wellbeing. The results will inform future policy decisions, including whether pausing or continuing milk feeds during transfusion should be adopted in routine neonatal care.

Participants needed: 90
Trial details
Age: Up to 30Biological sex: AllType: ObservationalSponsor: Imperial College LondonUpdated: Mar 30, 2026Locations: 7
Eligibility criteria

Preterm birth <30 gestational weeks

Parent(s) of a preterm baby who died of necrotising enterocolitis (NEC) [+2]

Status: Recruiting

Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study

Participants needed: 150
Trial details
Age: 7-5Biological sex: AllType: ObservationalSponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUpdated: Jun 17, 2025Locations: 1
Eligibility criteria

Infants born at <29 weeks' gestational age admitted to the NICU [+1]

Congenital heart disease (except an atrial (ASD) or ventricular septal defect (V... [+2]

Status: Recruiting

Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial

The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life. The main question it aims to answer is: Do fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth? Extremely premature babies who are receiving breathing support through a face mask will either: * Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or * Continue on face mask breathing support. All babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.

Participants needed: 164
Trial details
Age: Up to 30Biological sex: AllType: InterventionalSponsor: University College DublinUpdated: Oct 15, 2024Locations: 1
Eligibility criteria

Infants of any sex born before 28 weeks of gestation [+2]