- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02528227
NICU Parent Education Program (NICU PEP)
Přehled studie
Postavení
Intervence / Léčba
- Jiný: Know Your Baby Language Curriculum
- Jiný: Reading Aloud Language Curriculum
- Jiný: Sing A Long Language Curriculum
- Jiný: Mimicking First Sounds Language Curriculum
- Jiný: Language Games and Narrating Your Day Language Curriculum
- Jiný: Feeding Safety
- Jiný: Car Seat Safety
- Jiný: Bath Safety
- Jiný: Back to Sleep/SIDS prevention
- Jiný: Taking a Temperature and Signs of Infection
- Jiný: Infection Control Measures and Vaccine Information
Detailní popis
The long term goal of this research is to determine the language environment necessary in the NICU for very preterm infants to optimize their long-term language and cognitive development. This study will pilot an early language intervention with parents of preterm infants in the NICU the purpose of which is to provide a structured curriculum for the family to guide their language interactions with their infant. The aim is to increase the adult word counts and conversational turns in the NICU and to improve Bayley III language and cognitive scores at 12 months and 24 months corrected age.
The hypotheses is that increasing early language exposure in the NICU will result in improved lanugage and cognitive scores. The investigators plan on testing the hypothesis by the following specific aims.
- Determine the effectiveness of a structured language curriculum with parents of preterm infants in the NICU on increasing the amount of early language exposure.
- Test the the hypothesis that increased early language exposure will result in higher Bayley III language and cognitive scores.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Rhode Island
-
Providence, Rhode Island, Spojené státy, 02903
- Women and Infants' Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Receiving care at Women & Infants' Hospital NICU,
- Providence RI gestational age 23 - 32 weeks,
- RI resident
Exclusion Criteria:
- Unable to understand or speak English,
- congenital or chromosomal disorder likely to affect cognitive or speech development,
- parental loss of custody
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Language Curriculum
The Language Intervention group will receive some of the known methods for early language development.
Six lessons will include: Knowing your Baby, Reading Aloud, Sing-A-Long, Mimicking First Sounds, Language Game and Narrating Your Day.
Parents will receive feedback every 2 weeks from a Language Environment Analysis digital language processor (LENA).
|
Early language activities that parents can do with their infants
Early language activity that parents can do with their infants
Early language activity that parents can do with their infants
Early language activity that parents can do with their infants
Early language activity that parents can do with their infants
|
|
Komparátor placeba: Health and Safety Curriculum
Parents will receive six lessons on important infant safety topics including, feeding safety, care seat safety, bath safety, back to sleep/SIDS prevention, taking a temperature and signs of infection, infection control methods and vaccine information.
Parents will receive LENA feedback at discharge from NICU.
|
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bayley III cognitive composite score
Časové okno: 24 months
|
Bayley III cognitive score (mean 100, standard deviation 15)
|
24 months
|
|
Bayley III language composite score
Časové okno: 24 months
|
Bayley III Language score (mean 100, standard deviation 15)
|
24 months
|
|
Bayley III Expressive Language Score
Časové okno: 24 months
|
Bayley III Expressive Language (mean 10, standard deviation 3)
|
24 months
|
|
Bayley III Receptive Language Score
Časové okno: 24 months
|
Bayley III Receptive Language (mean 10, standard deviation 3)
|
24 months
|
|
Bayley III Motor Composite score
Časové okno: 24 months
|
Bayley III Motor composite score (mean 100, standard deviation 15)
|
24 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Infant vocalizations Count
Časové okno: 32 weeks post menstrual age
|
LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).
|
32 weeks post menstrual age
|
|
Infant vocalizations Count
Časové okno: 34 weeks post menstrual age
|
LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).
|
34 weeks post menstrual age
|
|
Infant vocalizations Count
Časové okno: 36 weeks post menstrual age
|
LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).
|
36 weeks post menstrual age
|
|
Conversational turns Count
Časové okno: 32 weeks post menstrual age
|
LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period).
|
32 weeks post menstrual age
|
|
Conversational turns Count
Časové okno: 34 weeks post menstrual age
|
LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period).
|
34 weeks post menstrual age
|
|
Conversational turns Count
Časové okno: 36 weeks post menstrual age
|
LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period).
|
36 weeks post menstrual age
|
|
Adult word count Count
Časové okno: 32 weeks post menstrual age
|
LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
|
32 weeks post menstrual age
|
|
Adult word count
Časové okno: 34 weeks post menstrual age
|
LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
|
34 weeks post menstrual age
|
|
Adult word count
Časové okno: 36 weeks post menstrual age
|
LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
|
36 weeks post menstrual age
|
|
Bayley III cognitive composite score
Časové okno: 12 month
|
Bayley III cognitive score (mean 100, standard deviation 15)
|
12 month
|
|
Bayley III motor composite score
Časové okno: 12 month
|
Bayley III motor score (mean 100, standard deviation 15)
|
12 month
|
|
Bayley III expressive language score
Časové okno: 12 month (mean 10, standard deviation 3)
|
Bayley III expressive language score (mean 100, standard deviation 15)
|
12 month (mean 10, standard deviation 3)
|
|
Bayley III receptive language score
Časové okno: 12 month (mean 10, standard deviation 3)
|
Bayley III receptive language score (mean 100, standard deviation 15)
|
12 month (mean 10, standard deviation 3)
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Elisabeth C McGowan, MD, Women and Infants' Hospital Providence RI
Publikace a užitečné odkazy
Obecné publikace
- Caskey M, Stephens B, Tucker R, Vohr B. Importance of parent talk on the development of preterm infant vocalizations. Pediatrics. 2011 Nov;128(5):910-6. doi: 10.1542/peds.2011-0609. Epub 2011 Oct 17.
- Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 12-0074
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .