Cambios posturales periódicos durante la fototerapia en neonatos a término y prematuros con hiperbilirrubinemia
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Parallel‐group randomised controlled trial | |
| Participants | Inclusion criteria: neonates born at 35 to 42 weeks of gestation, with age > 24 hours and < 14 days and hyperbilirubinaemia requiring phototherapy as per AAP nomogram were enrolled. Group differences: baseline variables like gestation, birth weight, serum bilirubin at the onset of phototherapy were comparable in the 2 groups. | |
| Interventions | Both groups: received single‐surface phototherapy with 4 blue and 2 white compact fluorescent tube lights. The light source was kept at 25 cm from the neonate. Supine group (n = 54): enrolled neonates were kept in supine posture whilst under phototherapy. Turning group (n = 46): position of neonate under phototherapy was changed between supine and prone positions every 2 hours. Neonates in both groups received exclusive breastfeeding. | |
| Outcomes | Reported outcomes included:
| |
| Notes | The study was conducted in New Delhi, India from June 2010 to July 2011. The phototherapy equipment was provided for the study purpose by the manufacturers. No interest to declare. No funding received. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “we randomly allocated enrolled infants using computer‐generated random sequence in two gestation strata (35 to 36 þ 6 weeks and X37 weeks) to either supine or turning every 2‐hour group.” |
| Allocation concealment (selection bias) | Low risk | Quote: “allocation codes were kept in serially numbered, sealed, and opaque envelopes to ensure concealment and were opened by the duty resident.” |
| Blinding of participants and personnel (performance bias) | High risk | Quote: “owing to obvious nature of intervention, blinding was not possible in our study.” |
| Blinding of outcome assessment (detection bias) | High risk | Outcome assessors were not blinded. |
| Incomplete outcome data (attrition bias) | Low risk | All the study outcomes were available for all randomised neonates. |
| Selective reporting (reporting bias) | Low risk | All the outcomes mentioned in the clinical trial registry have been reported. |
| Other bias | Low risk | None |
| Study characteristics | ||
| Methods | Parallel‐group randomised controlled trial | |
| Participants | Inclusion criteria: clinically well, term infants with non‐haemolytic hyperbilirubinaemia (bilirubin level greater than 15 mg/dL). Criteria for the diagnosis of non‐haemolytic hyperbilirubinaemia included: absence of blood group isoimmunisation, a negative Coombs' test, haemoglobin concentration greater than 14 g/dL, and a normal glucose‐6‐phosphate dehydrogenase status. Exclusion criteria: neonates with congenital anomalies and or who had significant bruising or large cephalohaematoma. Group differences: there were no significant differences between the 2 groups with respect to gender, feeding type, birth weight, gestational age, age at phototherapy, haemoglobin at the start of phototherapy, measured spectral irradiance, or duration of phototherapy. | |
| Interventions | Both groups: received single‐surface phototherapy with 6 white compact fluorescent tube lights. The light source was kept at 35 cm from the neonate. Supine group (n = 24): enrolled neonates were kept in supine posture whilst under phototherapy. Turning group (n = 27): the position of neonate under phototherapy was rotated from a supine to a prone position or vice versa every 2 hours. Phototherapy was interrupted for feeding. | |
| Outcomes | Outcomes reported by the study included:
| |
| Notes | The study was conducted in Taipei Medical University Hospital, Taipei, Taiwan. The study does not mention the study duration, any specific conflicts of interest, or funding source. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The method of sequence generation is not mentioned in the manuscript. Quote: “after entry into the study, infants were randomly assigned to a fixed‐position group or a position‐ changing group under conventional single‐direction phototherapy.” |
| Allocation concealment (selection bias) | Low risk | Quote: “group assignment was based on the sealed envelope technique.” |
| Blinding of participants and personnel (performance bias) | High risk | No information is provided about the blinding of the care providers. |
| Blinding of outcome assessment (detection bias) | High risk | No information is provided about the blinding of outcome assessors. |
| Incomplete outcome data (attrition bias) | Low risk | Although a trial flow chart is not provided, the outcomes were available for all enrolled neonates. |
| Selective reporting (reporting bias) | Low risk | Although information about registration of the trial is not provided, all important outcomes have been reported. |
| Other bias | Low risk | None |
| Study characteristics | ||
| Methods | Parallel‐group randomised controlled trial | |
| Participants | Inclusion criteria: healthy neonates with non‐haemolytic hyperbilirubinaemia, a gestational age of 33 weeks or more, fulfilling the indications for phototherapy, postnatal age > 24 hours, not having received phototherapy for the last 48 hours, and able to be treated in the cradle. Exclusion criteria: none defined. Group differences: no significant difference. | |
| Interventions | Both groups: received single‐surface phototherapy with an LED device emitting blue light with an emission peak at 470 nm and a bandwidth of 455 to 485 nm. The light source was kept at 20 cm from the neonate. Supine group (n = 53): enrolled neonates were kept in supine posture while under phototherapy. Turning group (n = 59): the position was changed every 3rd hour from supine to prone and vice versa. Neonates in both groups received feeding for 30 minutes every 3rd hour. | |
| Outcomes | Outcomes reported included:
| |
| Notes | The study was conducted in Aalborg Hospital, Aarhus University Hospital, Denmark from 1 March 2008 and 30 June 2009. The study does not mention any specific conflicts of interest. The study does not mention any funding source. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The study does not provide any information about the random allocation sequence generation. |
| Allocation concealment (selection bias) | Low risk | Quote: “randomized equally by sealed opaque envelopes to one of two phototherapy regimens” |
| Blinding of participants and personnel (performance bias) | High risk | The study does not provide any information about blinding of the care providers or outcome assessors. Due to the nature of the intervention, blinding of the care providers would not have been possible. |
| Blinding of outcome assessment (detection bias) | High risk | The study does not provide any information about blinding of the care providers or outcome assessors. |
| Incomplete outcome data (attrition bias) | Low risk | All the study outcomes are available for all randomised neonates. |
| Selective reporting (reporting bias) | Unclear risk | Only information about rate of fall of serum bilirubin and absolute values of serum bilirubin is provided. No information is provided about duration of hospital stay and need of exchange transfusion. Due to lack of information about the trial registry, it cannot be deduced whether all the predefined outcomes have been reported. |
| Other bias | Low risk | None |
| Study characteristics | ||
| Methods | Parallel‐group randomised controlled trial | |
| Participants | Inclusion criteria: healthy, exclusively breastfed, > 48 hours of postnatal age, birth weight > 2500 g, gestation at birth 38 to 41 weeks, and born after uncomplicated pregnancy if have indirect hyperbilirubinaemia with serum total bilirubin ≥ 15 mg/dL at 49 to 72 hours of age, or > 17 mg/dL at equal to or more than 72 hours of age. Exclusion criteria: neonates with haemolytic disease, infection, congenital anomaly, closed haemorrhage (cephalohaematoma), and metabolic disease. Group differences: the groups were comparable. | |
| Interventions | Both groups: received single‐surface phototherapy with 4 blue compact fluorescent tube lights. The light source was kept at 20 cm from the neonate. Supine group (n = 25): enrolled neonates were kept in supine posture whilst under phototherapy. Turning group (n = 25): position of neonate under phototherapy changed from supine to prone every 150 minutes followed by break of 30 minutes for feeding and routine nursing care. Neonates in both groups received exclusive breastfeeding as per enrolment criteria. Feeding schedule of the turning group is provided in the description of the intervention. Feeding schedule of the supine group is not described. | |
| Outcomes | Outcomes reported included:
| |
| Notes | The study was conducted in Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran. The duration of the study is not mentioned. The study does not mention any specific conflicts of interest. The study does not mention any funding source. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The manuscript does not provide any information about random allocation sequence generation. |
| Allocation concealment (selection bias) | Unclear risk | The manuscript does not provide any information about allocation concealment. |
| Blinding of participants and personnel (performance bias) | High risk | The manuscript does not provide any information about blinding. However, due to the nature of the intervention, blinding of care providers was not possible. |
| Blinding of outcome assessment (detection bias) | High risk | The manuscript does not provide any information about blinding of outcome assessors. |
| Incomplete outcome data (attrition bias) | Low risk | All the study outcomes are available for all randomised neonates. |
| Selective reporting (reporting bias) | Unclear risk | The trial registration information or study protocol is not available. Information about some important outcomes like duration of hospital stay and need of exchange transfusion is not provided. |
| Other bias | Low risk | None |
| Study characteristics | ||
| Methods | Parallel‐group randomised controlled trial | |
| Participants | Inclusion criteria: healthy term infants with birth weight above 2500 g, serum total bilirubin concentration above 18 mg/dL at the start of phototherapy. Of note, this study also included neonates with haemolytic jaundice. Exclusion criteria: congenital malformations. Group differences: none. | |
| Interventions | Both groups: received single‐surface phototherapy with 2 blue and 2 white compact fluorescent tube lights. The light source was kept at 23 to 25 cm from the neonate. Supine group (n = 16): enrolled neonates were positioned supine only and received 30‐minute break for feeding and nursing care every 150 minutes. Turning group (n = 14): enrolled neonates were positioned alternately supine or prone every 180 minutes (150 minutes of phototherapy and 30 minutes for feeding and nursing care). | |
| Outcomes | Outcomes reported included:
| |
| Notes | The study was conducted in Soroka University Medical Center, Israel. The duration of the study is not mentioned. The study does not mention any specific conflicts of interest. The study does not mention any funding source. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The manuscript does not provide any information about the allocation sequence generation. |
| Allocation concealment (selection bias) | Low risk | The investigator opened a sealed, opaque envelope at random. |
| Blinding of participants and personnel (performance bias) | High risk | The manuscript does not provide any information about the blinding of care providers. However, due to the nature of the intervention, blinding would not have been possible. |
| Blinding of outcome assessment (detection bias) | High risk | The manuscript does not provide any information about the blinding of outcome assessors. |
| Incomplete outcome data (attrition bias) | High risk | 2 neonates received a higher level of intervention, which could have been due to failure of treatment being investigated. These 2 neonates were excluded from the analysis. |
| Selective reporting (reporting bias) | Unclear risk | Trial registry information or study protocol is not available. |
| Other bias | Low risk | None |
AAP: American Academy of Pediatrics; LED: light‐emitting device
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| This study reports the results of 2 prospective surveys on phototherapy for neonatal jaundice and evaluates the influence of the intensity of the irradiance, mode, and continuous or discontinuous phototherapy. | |
| Non‐random allocation | |
| Systematic review | |
| Different intervention; partly clothed versus naked | |
| Review not meeting inclusion criteria; covers other issues related to neonatal hyperbilirubinaemia | |
| Non‐random allocation |
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | Randomised controlled trial |
| Participants | Included: neonates born at term gestation with weight more than 2500 g and serum bilirubin level 15 to 23 mg/dL. Exclusion criteria: congenital malformation, aged more than 10 days, ABO incompatibility, haemolytic jaundice, any signs of infection including sepsis, serum total bilirubin concentration above 23 mg. |
| Interventions | Changing baby position every 150 minutes versus fixed supine position |
| Outcomes |
|
| Notes | Study results not published. We contacted the authors, but the study results were not available. |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Duration of phototherapy Show forest plot | 4 | 231 | Mean Difference (IV, Random, 95% CI) | 1.71 [‐3.17, 6.59] |
| Analysis 1.1  Comparison 1: Turning position versus supine under phototherapy, Outcome 1: Duration of phototherapy | ||||
| 1.2 Per cent fall in bilirubin at 24 hours of starting phototherapy Show forest plot | 3 | 193 | Mean Difference (IV, Random, 95% CI) | ‐1.17 [‐6.44, 4.10] |
| Analysis 1.2  Comparison 1: Turning position versus supine under phototherapy, Outcome 2: Per cent fall in bilirubin at 24 hours of starting phototherapy | ||||
| 1.3 Rate of fall of serum total bilirubin at 24 hours of starting phototherapy Show forest plot | 1 | 100 | Mean Difference (IV, Random, 95% CI) | 0.02 [‐0.02, 0.06] |
| Analysis 1.3  Comparison 1: Turning position versus supine under phototherapy, Outcome 3: Rate of fall of serum total bilirubin at 24 hours of starting phototherapy | ||||
| 1.4 Serum total bilirubin at 24 hours of starting phototherapy Show forest plot | 4 | 292 | Mean Difference (IV, Random, 95% CI) | 0.22 [‐0.43, 0.86] |
| Analysis 1.4  Comparison 1: Turning position versus supine under phototherapy, Outcome 4: Serum total bilirubin at 24 hours of starting phototherapy | ||||
Study flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1: Turning position versus supine under phototherapy, Outcome 1: Duration of phototherapy
Comparison 1: Turning position versus supine under phototherapy, Outcome 2: Per cent fall in bilirubin at 24 hours of starting phototherapy
Comparison 1: Turning position versus supine under phototherapy, Outcome 3: Rate of fall of serum total bilirubin at 24 hours of starting phototherapy
Comparison 1: Turning position versus supine under phototherapy, Outcome 4: Serum total bilirubin at 24 hours of starting phototherapy
| Turning position versus supine under phototherapy in term and preterm neonates with hyperbilirubinaemia | ||||||
| Patient or population: term and preterm neonates with hyperbilirubinaemia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No. of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with turning position under phototherapy | Risk with supine position under phototherapy | |||||
| Duration of phototherapy (hours) | The mean duration of phototherapy ranged from 24.8 to 52.8 hours. | The mean duration of phototherapy ranged from 25.5 to 53.3 hours. | Mean duration of phototherapy was on average 1.71 hours longer in the turning group (95% CI −3.17 to 6.59). | 231 | ⊕⊕⊝⊝ | Periodic change in body position may lead to little or no difference in the duration of phototherapy. |
| Rate of fall of serum total bilirubin at 24 hours of starting phototherapy (mg/dL/h)b | The mean rate of fall of serum total bilirubin at 24 hours of starting phototherapy was 0.22 mg/dL/h. | The mean rate of fall of serum total bilirubin at 24 hours of starting phototherapy was 0.2 mg/dL/h. | MD in the rate of fall of serum total bilirubin was an average of 0.02 mg/dL/h higher in the turning group | 100 | ⊕⊕⊝⊝ Lowc | Periodic change in body position may lead to little or no effect on the rate of fall of serum total bilirubin at 24 hours of starting phototherapy. |
| Need for exchange transfusion | None of the studies reported this outcome. | |||||
| Bilirubin‐induced neurological damage (BIND) | None of the studies reported this outcome. | |||||
| Sudden infant death syndrome (SIDS) | None of the studies reported this outcome. | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded by two levels because of statistical heterogeneity and unclear risk of selection bias. (One study has attrition bias. Three studies have unclear reporting. Blinding of outcome assessors was not possible in any of the studies.) | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Duration of phototherapy Show forest plot | 4 | 231 | Mean Difference (IV, Random, 95% CI) | 1.71 [‐3.17, 6.59] |
| 1.2 Per cent fall in bilirubin at 24 hours of starting phototherapy Show forest plot | 3 | 193 | Mean Difference (IV, Random, 95% CI) | ‐1.17 [‐6.44, 4.10] |
| 1.3 Rate of fall of serum total bilirubin at 24 hours of starting phototherapy Show forest plot | 1 | 100 | Mean Difference (IV, Random, 95% CI) | 0.02 [‐0.02, 0.06] |
| 1.4 Serum total bilirubin at 24 hours of starting phototherapy Show forest plot | 4 | 292 | Mean Difference (IV, Random, 95% CI) | 0.22 [‐0.43, 0.86] |
