From womb to world: creating womb-like environments for preterm language development

Registry ID
ISRCTN94815142
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Oxford Brookes University
Enrollment
150
Start date
2026-03-01
Completion date
2029-09-30
Last update
2026-08-17

Conditions

Summary

Babies born preterm

Detailed description

This study will explore whether providing a womb-like sound environment can support early language development in babies born prematurely. Around 150 babies will take part in total: 50 preterm babies who experience a womb-like sound environment in the Neonatal Care Unit (NCU) 50 preterm babies who receive standard neonatal care 50 babies born full-term, who will act as a comparison group All babies will be healthy, with no known hearing, vision, or major medical problems. Parents will be given full information and asked to provide written consent before taking part. What will happen in the Neonatal Care Unit: For families who agree to take part in the womb-like sound group, parents will be asked to make simple audio recordings of their everyday speech at home using a small, discreet recording device for four days. These recordings will then be carefully processed so that they sound similar to how speech is heard in the womb (softened and filtered). No identifiable raw recordings will be stored. Meanwhile, a general recording of infant-directed speech produced by the research team will be used until parental recordings are available. While the baby is in the NCU, these sounds will be played at safe, carefully monitored levels through external speakers placed outside the incubator or cot. No equipment will be placed inside the baby’s bed space. The sound system can be stopped at any time if needed, and it will never interfere with medical care. Babies will be exposed to the sounds until they leave the NCU or reach their due date. Babies in the standard care group will not receive any additional sounds beyond usual NCU care. What will happen after discharge: All babies will be followed over their first year of life. They will be invited to take part in four short research visits at the Brookes BabyLab at 7.5, 9, 10.5, and 12 months of age. At each visit: Babies will take part in short listening tasks (about 5 minutes each), where their looking or listening resp

Interventions

Inclusion criteria

Preterm Infant Group: 1. Gestational age ≥26 and ≤34 weeks. 2. Absence of major cerebral damage (e.g., periventricular leukomalacia, intra-ventricular haemorrhage…). 3. No indication of visual or hearing impairment. 4. No family risks of developmental or language disorders. 5. From monolingual English-speaking families. Full-term Infant Group: 1. Gestational age ≥37 weeks. 2. Absence of major cerebral damage (e.g., periventricular leukomalacia, intra-ventricular haemorrhage…). 3. No indication of visual or hearing impairment. 4. No family risks of developmental or language disorders. 5. From monolingual English-speaking families.

Exclusion criteria

Preterm Infant Group 1. Born before 26 weeks’ gestation or after 34 weeks’ gestation. 2. Evidence of major brain injury or neurological damage, including but not limited to periventricular leukomalacia or intraventricular haemorrhage. 3. Known or suspected hearing impairment or visual impairment. 4. Presence of diagnosed genetic, neurological, developmental, or language disorders, or a known family history of developmental or language disorders that may affect language development. 5. Infants from bilingual or multilingual households, or where English is not the primary language spoken to the infant at home. 6. Medical instability or clinical concerns identified by the neonatal care team that would make participation inappropriate or place additional burden on the infant or family. Full-term Infant Group 1. Born before 37 weeks’ gestation. 2. Evidence of major brain injury or neurological damage, including but not limited to periventricular leukomalacia or intraventricular haemorrhage. 3. Known or suspected hearing impairment or visual impairment. 4. Presence of diagnosed genetic, neurological, developmental, or language disorders, or a known family history of developmental or language disorders that may affect language development. 5. Infants from bilingual or multilingual households, or where English is not the primary language spoken to the infant at home. 6. Any medical condition or clinical concern identified by the clinical or research team.

Locations

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