Meta AnalysisID 2826
吲哚美辛治疗早产儿症状性动脉导管未闭 [Cochrane方案]
CRD42019146012
To determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic patent ductus arteriosus (PDA).
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 2826
- Evidence Id
- 11384
- Core Evidence Id
- 11384
- Source Meta Analysis Id
- 2769
- Herb2 Meta Analysis Id
- HBMA002769
- Crd Id
- CRD42019146012
- Title
- Indomethacin for symptomatic patent ductus arteriosus in preterm infants [Cochrane protocol]
- Review Question
- To determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic patent ductus arteriosus (PDA).
- Study Type Included
- We will include all published and unpublished RCTs, quasi-RCTs, and cluster-RCTs, and randomized crossover trials. Both superiority trials and non-inferiority trials are eligible for inclusion.
- Condition Being Studied
- The Cochrane Neonatal Group
- Participant
- Preterm infants born at less than 37 weeks' gestation or low birth weight infants (< 2500 grams) treated for symptomatic PDA enrolled within the first 28 days of life. Symptomatic PDA is defined by clinical, echocardiographic, and Doppler criteria. Clinical criteria include a characteristic heart murmur, hyperdynamic precordial impulse, tachycardia, bounding pulses, widened pulse pressure, or worsening respiratory status (<link ref=REF-Davis-1995 type=REFERENCE/>Davis 1995). Echocardiographic and Doppler criteria include a transductal diameter greater than 1.5 mm, left atrial aortic root ratio (LA:Ao) greater than 1.3, a left to right shunt, and “disturbed diastolic flow in the main pulmonary artery with diastolic backflow in the aorta immediately below the ductus arteriosus and forward flow above the ductal insertion” (<link ref=REF-Lago-2002 type=REFERENCE/>Lago 2002). We will exclude infants with other known congenital heart disease or infants with prior treatment with a cyclooxygenase inhibitor (indomethacin, ibuprofen).
- Animal
- Human Disease Modelled
- Intervention
- Indomethacin (any dose, any route) versus placebo or no treatment. For technical reasons the intervention and comparators fields for Cochrane protocols are identical and each may include information on both interventions and comparators
- Comparator Control
- Indomethacin (any dose, any route) versus placebo or no treatment. For technical reasons the intervention and comparators fields for Cochrane protocols are identical and each may include information on both interventions and comparators
- Main Outcome
- <ol> PDA closure within one week of administration of the first dose of indomethacin Bronchopulmonary dysplasia (defined as supplemental oxygen need at 28 days postnatal age (<link ref=REF-Bancalari-1979 type=REFERENCE/>Bancalari 1979), or supplemental oxygen at 36 weeks' postmenstrual age with or without compatible clinical and radiographic findings (<link ref=REF-Shennan-1988 type=REFERENCE/>Shennan 1988)) All-cause neonatal mortality at 28 days and prior to hospital discharge</ol>
- Outcome Measure
- Additional Outcome
- <heading level=4>PDA-related outcomes</heading> Proportion of infants receiving rescue medical treatment (repeated cyclooxygenase or paracetamol/acetaminophen dosing, or both) Proportion of infants requiring surgical ligation or transcatheter occlusion<heading level=4>Other outcomes</heading><ol> Pneumothorax Pulmonary hemorrhage Late onset-sepsis NEC (Bell stage 2 or greater) (<link ref=REF-Bell-1978 type=REFERENCE/>Bell 1978) IVH (any grade) (<link ref=REF-Papile-1978 type=REFERENCE/>Papile 1978) Severe IVH (grade III to IV)(<link ref=REF-Papile-1978 type=REFERENCE/>Papile 1978) Periventricular leukomalacia Retinopathy of prematurity (any stage) (<link ref=REF-ICROP-2005 type=REFERENCE/>ICROP 2005) Severe retinopathy of prematurity (stage III or greater) Infant mortality (first year of life) Use of inotropic agents Duration of assisted ventilation (days) Duration of oxygen dependence (days to last discontinuation of any supplemental oxygen) Duration of hospital stay (days) Time to full enteral feeds (days) Neurodevelopmental outcome (Bayley Scales of Infant Development score at 18 to 28 months) Cerebral palsy at approximately two years corrected age (as defined by the study authors) Neurodevelopmental outcome at approximately two years corrected age (acceptable range 18 months to 28 months) including: cerebral palsy, delayed neurodevelopment (Bayley Scales of Infant Development Mental Developmental Index < 70), legal blindness (< 20/200 visual acuity), and hearing deficit (aided or < 60 dB on audiometric testing). The composite outcome 'neurodevelopmental impairment' was defined as having any one of the aforementioned deficits.</ol><heading level=4>Safety outcomes (harms reported within one week of completing intervention)</heading><ol> Intestinal perforation Renal function<ol> Oliguria (< 1 mL/kg/hour) Serum/plasma creatinine (µmol/L) levels during treatment Serum/plasma creatinine (µmol/L) after treatment</ol> Hemostasis<ol> Mucocutaneous or gastrointestinal bleeding Platelet count (< 50,000 platelets/µL blood)</ol> Pulmonary hypertension (diagnosed by echocardiographic or Doppler criteria)</ol>
- Study Method
- Intervention, Systematic review
- Keyword
- Ductus Arteriosus, Patent; Humans; Indomethacin; Infant; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases
- Contact
- Peter Evans [email protected]
- Organisational Affiliation
- The Cochrane Collaboration http://www.cochrane.org/
- Funding Source
- Vermont Oxford Network
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD013133/abstract
- Review Type
- Language
- English
- Country
- United States of America
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2019-08-05
- Anticipated Start Date
- 2018-09-15
- Anticipated Completion Date
- 2019-06-30
- Title Cn
- 吲哚美辛治疗早产儿症状性动脉导管未闭 [Cochrane方案]
- Title En
- Indomethacin for symptomatic patent ductus arteriosus in preterm infants [Cochrane protocol]
- Bilingual Status
- complete