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Early light reduction for preventing retinopathy of prematurity in very low birth weight infants

Retinopathy of prematurity (a common retinal neovascular disorder of premature infants) is a leading cause of childhood blindness worldwide. The cause of advanced retinopathy of prematurity and the way the disease develops are not fully understood. In the past many factors, such as the use of supplemental oxygen, excessive light exposure and hypoxia (lack of oxygen), have been suggested as possible causes. Light exposure has been investigated because experimental studies have demonstrated that intensive lighting can result in irreversible damage to the retina. However, the clinical studies conducted to date have shown conflicting results in terms of the effects of light in the development of the disease. Furthermore, studies have concluded that reduction of light exposure does not reduce the progression of retinopathy of prematurity.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Peripheral retinal ablation for threshold retinopathy of prematurity in preterm infants

Advances in perinatal medicine have led to increased survival of extremely low birth weight infants and an increase in the incidence of retinopathy of prematurity (ROP). This is a vascular proliferative disorder of the immature retina in premature infants that can result in impairment of vision and a high (> 47%) chance of blindness if untreated (threshold ROP). Normally the retina has a complete system of blood vessels by 40 weeks. Injury to the developing retinal capillaries occurring before or during birth and in the days following delivery stimulates new vascularization, which is the observable retinopathy. This can result in successful revascularization of the retina (regression of the ROP) or progression to neovascular membranes in the vitreous, subsequent scarring and retinal detachment. The incidence and severity of retinopathy is inversely related to gestational age. Treatment involves removal (ablation) of the part of the retina without blood vessels to preserve central macula vision. Cryoablation and laser techniques are used. The review authors identified two randomised trials involving 291 and 28 premature infants with threshold ROP, reported in the 1980s. Both used cryotherapy for peripheral retinal ablation, reducing the incidence of adverse ophthalmic outcomes. Unfavorable retinal structure at less than 12 months and in early childhood at 5½ years (234 infants) was reduced by some 18 to 20%. Therefore, the number of eyes with threshold ROP needed to treat (NNT) to avoid one unfavorable outcome is around five. The risk of poor visual acuity in early childhood was reduced from 63 to 51% (NNT 8).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

D‐Penicillamine for preventing retinopathy of prematurity in preterm infants

Retinopathy of prematurity (ROP) is an eye disease of premature infants that continues to be a serious problem. The drug D‐penicillamine, given by mouth, is commonly used to treat poisoning by iron or copper or other heavy metals. In research studies of D‐penicillamine used for another problem that premature infants have (high bilirubin), it was observed that the treated infants had less ROP. However, this systematic review did not show any significant benefits of this drug for the outcomes of ROP, death or development of nerves. Thus, the use of this drug cannot be recommended for the prevention of ROP based on available evidence.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Local anaesthetic eye drops for prevention of pain in preterm infants undergoing screening for retinopathy of prematurity

Infants born less than 1500 g or less than 32 weeks are at increased risk of retinopathy of prematurity, a potentially blinding eye condition, and so have routine ophthalmological assessment. This process is a recognised source of pain and discomfort for preterm infants. This review highlights that retinopathy of prematurity is a painful examination and that instillation of local anaesthetic eyedrops immediately prior to examination of the eye is associated with a reduction in pain scores, as assessed by validated pain scores. Ongoing research is required to determine the optimum local anaesthetic eyedrop and other potentially important methods of reducing pain, including swaddling, and sucrose.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Supplemental oxygen for the treatment of prethreshold retinopathy of prematurity

Increased oxygen supplementation for babies with signs of worsening retinopathy of prematurity (ROP) may not prevent development of this eye disease, and may lead to lung complications. Very preterm babies are at risk of damage to their sight from ROP (retinopathy of prematurity). Oxygen plays a part in the development of ROP. The amount of oxygen babies receive in neonatal intensive care is very carefully monitored to try to lower the risk of ROP and limit the possibility of lung damage. One option is increasing the oxygen level to babies who are showing signs of worsening ROP. However, the review of the one available trial found that increased supplemental oxygen did not reduce the chances of ROP progressing, but may harm the lungs of babies showing signs of worsening ROP.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Why are randomized trials important?

The story of a big randomized study in 1954 shows why it is so important to divide participants of a study into groups by chance. The study focused on the question if high doses of oxygen in the incubator can leave newborns blind. For many years, this had been the standard treatment without it having been thoroughly tested before.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: October 27, 2013

Early versus late discontinuation of oxygen in preterm or low birth weight infants

Not enough evidence to show the benefits or adverse effects of early oxygen weaning in preterm or low birthweight babies. Babies born either prematurely (before 37 weeks) or with a low birthweight often have breathing problems and need extra oxygen. Oxygen supplementation has provided many benefits for these babies and the ability to measure oxygen levels accurately can help reduce adverse effects. The correct time to wean babies off oxygen supplementation has been unclear but is usually measured by their age, weight gain and breathing ability. The review did not find enough evidence from trials to show the benefits or adverse effects of early oxygen weaning in preterm or low birth weight babies. More research is needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Selenium supplementation to prevent short‐term morbidity in preterm neonates

Higher doses of selenium supplements may be able to reduce some complications for preterm babies, but more research is needed. Selenium is an essential trace element gained from nutrients. Babies are born with lower selenium concentrations in their blood than their mothers. In very preterm babies, low selenium is associated with an increased risk of complications. The review of trials of selenium supplementation for preterm babies found that it reduces sepsis (blood infection). It has not been shown to reduce other complications or increase survival. No adverse effects were reported. Higher than usual levels of selenium supplementation may be beneficial, but more research is needed as most of the evidence comes from a country where selenium levels were unusually low.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Surgical versus medical treatment with cyclooxygenase inhibitors for symptomatic patent ductus arteriosus in preterm infants

The way an infant's blood is circulated changes soon after birth. Initially, premature infants have an opening (a patent ductus arteriosus, PDA) between the large blood vessel to the lungs and the large blood vessel that carries oxygenated blood to the rest of the body. Early symptomatic treatment of PDA, when clinical signs first appear, helps reduce the amount of time an infant needs assisted breathing (mechanical ventilation) and the likelihood of chronic lung disease and damaging inflammation of the gut (necrotising enterocolitis). Standard therapy includes restricting fluids, diuretics and cyclooxygenase inhibitors like indomethacin or ibuprofen. The PDA is closed surgically if these medical treatments do not work. Only one randomised controlled study could be included in this review (including 154 preterm infants that needed breathing support). Indomethacin and surgery gave similar benefits. There were no differences in deaths during the hospital stay, chronic lung disease, necrotising enterocolitis, cerebral or other bleeding. Surgery was more effective in closing the PDA (three needed to treat for one to benefit) but it was associated with complications (pneumothorax and retinopathy of prematurity). The one study found was carried out over 30 years ago. Clinical practice has changed a great deal and surgical closure of a PDA is safer. Therefore, whether the results of the study are applicable today is debatable. Updates of this review in July 2007 and February 2012 did not identify any additional randomised controlled studies for inclusion, but three observational studies indicated an increased risk for one or more of the following outcomes associated with PDA ligation: chronic lung disease, retinopathy of prematurity and neurosensory impairment.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Restricted versus liberal oxygen exposure for preventing morbidity and mortality in preterm or low birth weight infants

Restricting oxygen supplementation significantly reduces the rate and severity of vision problems (retinopathy) in premature and low birth weight babies. Babies born either prematurely (before 37 weeks) or with a low birth weight often have breathing problems and need extra oxygen. Oxygen supplementation has provided many benefits for these babies but can cause damage to the eyes (retinopathy) and lungs. The review of trials found that unrestricted oxygen supplementation has these potential adverse effects without any clear benefits. Restricted oxygen significantly reduces these risks. More research is needed to find the best level of oxygen supplementation.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Air versus oxygen for resuscitation of infants at birth

About 5 to 10% of infants need resuscitation at birth. Many experts recommend that these babies be resuscitated with 100% oxygen, but other experts think that normal room air is as good as or better than 100% oxygen. Too much oxygen can make breathing difficult for babies and can cause other problems such as problems with brain development, an eye condition (retinopathy of prematurity), and a lung condition (bronchopulmonary dysplasia). The authors of this Cochrane review questioned whether resuscitation with room air resulted in fewer deaths or disabilities than 100% oxygen. After searching the literature, they found five studies. There were a total of 1302 infants in these studies; 24% of them were premature. In the studies, fewer babies died when resuscitated with room air than with 100% oxygen. Many of the babies resuscitated with room air also got some oxygen as a supplement, making it difficult to compare the two groups. There were also other problems with the way the studies were carried out. The authors of the Cochrane review concluded that there is not enough evidence to recommend room air over 100% oxygen, or vice versa.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Early versus late erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants

The number of red blood cells falls after birth in preterm infants due to the natural breakdown of erythrocytes and blood letting. Low levels of erythropoietin (EPO), a substance in the blood that stimulates red blood cell production in preterm infants, provide a rationale for the use of EPO to prevent or treat anaemia. A total of 262 infants born preterm have been enrolled in two studies of early versus late administration of EPO to prevent blood transfusions. There were no demonstrable benefits of early versus late administration of EPO with regards to reduction in the use of red blood cell transfusions, number of transfusions, the amount of red cells transfused or number of donor exposures per infant. However, the use of early EPO compared with late EPO administration increases the risk of retinopathy of prematurity, a serious complication in babies born before term. Currently, there is a lack of evidence that either treatment confers any substantial benefits with regard to any donor blood exposure, as many infants enrolled in both studies were exposed to donor blood prior to study entry, and early EPO increases the risk of retinopathy of prematurity. Neither early nor late administration of EPO is recommended.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Late erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants

We reviewed the evidence about the effectiveness and safety of late initiation of erythropoietin treatment between eight and 28 days after birth, in reducing the use of red blood cell (RBC) transfusions in preterm and/or low birth weight infants.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Superoxide dismutase for preventing chronic lung disease in mechanically ventilated preterm infants

Not enough evidence to show the effectiveness of superoxide dismutase in preventing chronic lung disease in premature babies. Chronic lung disease (CLD) is a common problem in preterm babies who are mechanically ventilated (machine assisted breathing). Free oxygen radicals are believed to cause CLD. Superoxide dismutase is an enzyme normally present in the body to provide a defence against free radicals but preterm infants do not have a sufficient supply to provide natural resistance. Giving superoxide dismutase to preterm infants may therefore prevent CLD. The review of trials found there is not enough evidence yet to show if this is effective. More research is needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Vasopressin and its analogues for the treatment of refractory hypotension in neonates

Hypotension or low blood pressure occurs frequently in newborn infants after infection or surgery or in very preterm infants. Sometimes, the hypotension does not respond to fluids or other drug such as catecholamines or steroids. In those unresponsive infants, vasopressin may be useful in improving blood pressure and overall survival. We searched the literature for studies that used vasopressin or its analogue terlipressin in the newborn in the first 28 days of life for unresponsive hypotension. We found no ongoing or completed studies. Currently there is no evidence to recommend the use of vasopressin or terlipressin, but we recommend that studies be carried out in the future to study the effectiveness and safety in unresponsive hypotension in newborn infants.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Tracheal gas insufflation for the prevention of morbidity and mortality in mechanically ventilated newborn infants

Tracheal gas insufflation (TGI) is a new technique to supplement mechanical ventilation in neonatal intensive care, but benefit and safety have not been proven. Tracheal gas insufflation (TGI ‐ also called 'dead space washout') is a new add‐on technique for mechanical ventilation (machine‐assisted breathing) for babies in neonatal intensive care. It requires new and expensive specialised equipment and skills. TGI involves sending a continuing flow of air/oxygen into the lower part of a baby's trachea (windpipe). The review found only one trial of TGI, which showed it might reduce the length of time babies need mechanical ventilation, but not necessarily reduce the time on oxygen therapy or the stay in hospital. More research is needed to establish if this technology is safe and beneficial.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2010

Prophylactic protein free synthetic surfactant for preventing morbidity and mortality in preterm infants

Pulmonary surfactant is a substance that prevents the air sacs of the lungs from collapsing by reducing surface tension. Surfactant is essential to normal lung function in newborn babies. Sometimes it is absent in immature lungs and respiratory distress syndrome (RDS) can develop. Protein free synthetic surfactants have been developed and can be used for babies born prematurely (before 34 weeks) who are at risk of developing RDS. The review of trials found evidence that synthetic surfactant reduced the risk of RDS in babies considered at risk. Babies who receive prophylactic synthetic surfactant have a decreased risk of RDS, pneumothorax (air in the lung cavity) and death. However, babies who receive prophylactic synthetic surfactant have an increased risk of developing lung hemorrhage and patent ductus arteriosus, an open vessel that channels blood from the lungs to the body. Although this can lead to potentially life threatening complications, the overall benefits of surfactant treatment outweigh the risks.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2010

Antistaphylococcal immunoglobulins to prevent staphylococcal infection in very low birth weight infants

Babies born at earlier gestation and who are born with low birth weight are at significant risk of sepsis. This is in part due to the immaturity of the immune defence system, including low levels of immunoglobulins. Researchers attempted to boost the immune system by artificially providing antibodies specific to the most common bacteria causing such infections. Three studies reviewed here (two of which are pilot studies) revealed neither benefit nor risk associated with the preventative use of specific antibodies to common bacterial infections.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Interventions for treatment of neonatal hyperglycemia in very low birth weight infants

Higher‐than‐normal blood sugar levels are frequently seen in babies born very early (before 32 weeks gestation) or with very low birth weight (< 1500 grams) and who are fed totally or partially by vein. Several types of adverse outcomes have been associated with high blood sugar levels, including increased risks for death, infections, eye problems, and bleeding into the brain. It is not known if treatment to lower the baby's blood sugar helps to prevent those complications and, if so, which treatment is best. These treatment options include decreasing the amount of sugar delivered by vein to nourish the baby or administration of insulin. This review of trials found no evidence of significant effects of these treatments on the risks of death or major complications. However, the studies reviewed were very small. There is a need for larger trials to answer these questions.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Elective high frequency ventilation compared to conventional mechanical ventilation in the early stabilization of infants with respiratory distress

Background. Respiratory failure due to lung immaturity is a major cause of deaths in preterm infants. Although the use of intermittent positive pressure ventilation in newborns with respiratory failure saves lives, its use is associated with lung injury and chronic lung disease. A newer form of ventilation called high frequency oscillatory ventilation has been shown in experimental studies to result in less lung injury.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

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