Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
Anahtar kelimeler
Öz
Açıklama
Prophylactic indomethacin reduces patent ductus arteriosus (PDA) and intraventricular hemorrhage in very low birth weight infants. However, the effects of early indomethacin on long-term neurodevelopment remain uncertain. There is also insufficient evidence to rule out serious adverse effects, such as increases in the risk of necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). The aim of this trial was to determine if prophylactic administration of indomethacin improves survival without neurosensory impairments in extremely-low-birth-weight infants. Infants (n=1202) with birthweights 500 to 999 grams were randomized between 2 and 6 hours after birth to receive either intravenous indomethacin (0.1 mg/kg) or equal volumes of normal saline placebo, daily for 3 days. The primary outcomes at a corrected age of 18 months was a composite of death, cerebral palsy, cognitive delay, deafness, or blindness. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, cranial ultrasonographic abnormalities, nectrotizing enterocolitis and retinopathy. Infants were evaluated in follow-up at 18-22 months corrected age.
Tarih
| Son Doğrulandı: | 05/31/2015 |
| İlk Gönderilen: | 01/31/2001 |
| Tahmini Kayıt Gönderildi: | 02/01/2001 |
| İlk Gönderilen: | 02/04/2001 |
| Son Güncelleme Gönderildi: | 06/02/2015 |
| Son Güncelleme Gönderildi: | 06/07/2015 |
| Fiili Çalışma Başlangıç Tarihi: | 10/31/1993 |
| Tahmini Birincil Tamamlanma Tarihi: | 02/28/1999 |
| Tahmini Çalışma Tamamlanma Tarihi: | 02/28/2001 |
Durum veya hastalık
Müdahale / tedavi
Drug: Indomethacin
Drug: Indomethacin
Drug: Placebo
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Experimental: Indomethacin Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa. | Drug: Indomethacin Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa |
| Placebo Comparator: Placebo Saline solution | Drug: Placebo 0.1 mg per kilogram of body weight |
Uygunluk kriterleri
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | Inclusion Criteria: - Birth weight 500 to 999 grams; - Postnatal age greater than 2 hours; Exclusion Criteria: - Unable to administer study drug within 6 hours of birth; - Structural heart disease and/or renal disease; - Dysmorphic features or congenital abnormalities; - Tocolytic therapy with indomethacin or other prostaglandin inhibitor within 72 hours prior to delivery; - Overt clinical bleeding from more than one site; - Platelet count less than 50 x 109/L; - Hydrops; - Not considered viable |
Sonuç
Birincil Sonuç Ölçütleri
1. Death or Neurodevelopment Impairment [18-22 Months Corrected Age]
İkincil Sonuç Ölçütleri
1. Patent ductus arteriosus [120 Days of Life]
2. Bronchopulmonary Dysplasia (BPD) [120 Days of Life]
3. Necrotizing enterocolitis (NEC) [120 Days of Life]
4. Intracranial abnormalities [120 Days of Life]
5. Retinopathy of Prematurity (ROP) [18-22 Months Corrected Age]
6. Pulmonary hemorrhage [120 Days of Life]
