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New tool could help spot brain issues in At-Risk newborns earlier

NCT ID NCT07182513

Knowledge-focused Sponsor: Kahramanmaras Sutcu Imam University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study is translating and testing a Turkish version of the Hammersmith Neonatal Neurological Examination (HNNE) for high-risk infants, such as premature babies or those with birth complications. Researchers will check if the exam is reliable and valid for use in Turkey by comparing scores from 120 infants. The goal is to give doctors a better way to catch early signs of cerebral palsy and other developmental problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide Turkish healthcare professionals with a reliable tool to detect neurological problems early in high-risk infants, potentially improving outcomes through timely intervention.
What could go wrong
This is an observational validation study, not a treatment trial. It will not directly improve health, and the tool may not predict long-term outcomes as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

126 people

The number who actually took part.

Started

Aug 2025

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Neonatal infants at term equivalent age (TEA) of 37-42 weeks with high risk of cerebral palsy

Ages

37 to 42 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Infants with periventricular hemorrhage, intracranial hemorrhage grades 2, 3, or 4, cystic periventricular leukomalacia (PVL), stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterus), perinatal stroke, perinatal asphyxia, and hydrocephalus. 2. Infants with chronic lung disease, respiratory lung disease (RDS), bronchopulmonary dysplasia (BPD), and long-term oxygen supplementation. 3. Preterm infants with sepsis due to gram-negative bacteria, necrotizing enterocolitis (NEC), and infantile apnea. 4. Preterm infants with a low 5-minute Apgar score (3 or below), diagnosed with intrauterine growth restriction, multiple births (twins, triplets), and preterm infants with Retinopathy of Prematurity (ROP). 5. Infants with prolonged severe hypoglycemia and hypocalcemia. 6. Babies who are small for gestational age (SGA), less than the 3rd percentile, or large for gestational age (LGA), greater than the 97th percentile. 7. Babies receiving mechanical ventilation for more than 24 hours. 8. Babies born at less than 32 weeks' gestation and weighing less than 1500 grams. Exclusion Criteria: 1. Babies with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.) 2. Babies diagnosed with metabolic and genetic diseases (Down syndrome, spinal muscular atrophy, Duchenne muscular dystrophy, etc.) 3. Babies still intubated and mechanically ventilated at 3 months postterm

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia cerebral palsy childhood acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral palsy (CP) Infant ALL Neonatal Neurological development

Contacts and locations

Locations

  • Kahramanmaraş Sütçü imam University

    Kahramanmaraş, Onikişubat, 46100, Turkey (Türkiye)

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