| INTERVENTIONS |
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Intervention type
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Intervention name
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Dose
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Duration
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Intervention description
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Group size
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Nature of control
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| Experimental Group |
Fiberoptic phototherapy |
The BiliBlu LED fiberoptic phototherapy unit has a body surface area of 25cm x 40cm,with a constant setting of 34 microW/cm2/nm light irradiance. This was wrapped around the newborn |
Once a newborn’s total serum bilirubin levels reached the threshold phototherapy level on the AAP phototherapy nomogram, phototherapy was initiated.Serum bilirubin reduction rate was measured to monitor response to treatment, this was assessed as the decline in the TSB levels for the duration of exposure to phototherapy, expressed as a percentage of decline per hour. This was monitored through daily (every 24 hours of exposure) sampling of blood for total serum bilirubin. Treatment failure was defined as the need for additional phototherapy units (‘double phototherapy ‘) determined by serial serum bilirubin response while on phototherapy, of which a rise in serum bilirubin level more than 9 μmol /L per hour after phototherapy initiation was an indicator for double phototherapy. Phototherapy was stopped when serum bilirubin levels were <50micromol/l on the AAP nomogram, and treatment duration was then assessed as the duration of time exposure to phototherapy in hours. |
A parallel randomized control trial to test three treatment groups was conducted in the neonatal care unit (NCU) at the Kilimanjaro Christian Medical Centre (KCMC) in Northern Tanzania from January 2019 to May 2019. The NCU has a bed capacity of 62 babies, with an average of 6 enrolled and registered nurses caring for neonates per shift. The babies are nursed in locally made heated cots which use incandescent bulbs to heat up the cot. In our neonatal care unit, phototherapy is the only treatment modality used for unconjugated hyperbilirubinaemia.
65 term neonates (>37 weeks of gestation), less than 7 days of age, admitted with jaundice, were identified by clinicians working in the neonatal unit and screened for eligibility. We included those with hemolytic and non-hemolytic unconjugated hyperbilirubinemia with a total bilirubin level that has reached phototherapy threshold values as per the American Academy of Pediatrics (AAP) nomogram, which is a validated tool used for making decision regarding phototherapy in infants with unconjugated hyperbilirubinemia. Newborns receiving phenobarbitone; newborns with bilirubin levels that have reached exchange transfusion levels on the AAP nomogram; newborns with conjugated hyperbilirubinaemia; newborns who have already received phototherapy prior to enrollment and those whose parents refused to consent were excluded from the study. The study proposal was reviewed and approved by the ethics committee of the Kilimanjaro Christian Medical University College.
Once a newborn’s total serum bilirubin levels reached the threshold phototherapy level on the
AAP phototherapy nomogram, we offered parents or guardians verbal and written information on phototherapy, including all of the following: why phototherapy is being considered, why phototherapy may be needed to treat hyperbilirubinaemia, the possible side effects of phototherapy, the need for eye protection and routine eye care, reassurance that short breaks for feeding, nappy cha |
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| Control Group |
Blue light conventional phototherapy |
The blue light PT unit “Olympic Bili-Lit model 66”, consists of four blue fluorescent bulbs placed 20 cm above the newborn with a constant irradiance of 27 µW/cm2/nm. Eye pads were used to prevent damage to the retina. |
Once a newborn’s total serum bilirubin levels reached the threshold phototherapy level on the AAP phototherapy nomogram, phototherapy was initiated.Serum bilirubin reduction rate was measured to monitor response to treatment, this was assessed as the decline in the TSB levels for the duration of exposure to phototherapy, expressed as a percentage of decline per hour. This was monitored through daily (every 24 hours of exposure) sampling of blood for total serum bilirubin. Treatment failure was defined as the need for additional phototherapy units (‘double phototherapy ‘) determined by serial serum bilirubin response while on phototherapy, of which a rise in serum bilirubin level more than 9 μmol /L per hour after phototherapy initiation was an indicator for double phototherapy. Phototherapy was stopped when serum bilirubin levels were <50micromol/l on the AAP nomogram, and treatment duration was then assessed as the duration of time exposure to phototherapy in hours. |
A parallel randomized control trial to test three treatment groups was conducted in the neonatal care unit (NCU) at the Kilimanjaro Christian Medical Centre (KCMC) in Northern Tanzania from January 2019 to May 2019. The NCU has a bed capacity of 62 babies, with an average of 6 enrolled and registered nurses caring for neonates per shift. The babies are nursed in locally made heated cots which use incandescent bulbs to heat up the cot. In our neonatal care unit, phototherapy is the only treatment modality used for unconjugated hyperbilirubinaemia.
65 term neonates (>37 weeks of gestation), less than 7 days of age, admitted with jaundice, were identified by clinicians working in the neonatal unit and screened for eligibility. We included those with hemolytic and non-hemolytic unconjugated hyperbilirubinemia with a total bilirubin level that has reached phototherapy threshold values as per the American Academy of Pediatrics (AAP) nomogram, which is a validated tool used for making decision regarding phototherapy in infants with unconjugated hyperbilirubinemia. Newborns receiving phenobarbitone; newborns with bilirubin levels that have reached exchange transfusion levels on the AAP nomogram; newborns with conjugated hyperbilirubinaemia; newborns who have already received phototherapy prior to enrollment and those whose parents refused to consent were excluded from the study. The study proposal was reviewed and approved by the ethics committee of the Kilimanjaro Christian Medical University College.
Once a newborn’s total serum bilirubin levels reached the threshold phototherapy level on the
AAP phototherapy nomogram, we offered parents or guardians verbal and written information on phototherapy, including all of the following: why phototherapy is being considered, why phototherapy may be needed to treat hyperbilirubinaemia, the possible side effects of phototherapy, the need for eye protection and routine eye care, reassurance that short breaks for feeding, nappy changing and cuddles will be encouraged, and what might happen if phototherapy fails. Detailed explanation of what will happen during phototherapy was also provided: the newborn will be nursed in a supine and prone position unless other clinical conditions prevent this, treatment will be applied to the maximum area of skin, newborn's temperature will be monitored, and the hydration of the newborn will be assessed by daily weighing. Formal consent was obtained from the parent of the study participant. We observed confidentiality of the names of the study participants by using code numbers. We included 41 term neonates who met the inclusion criteria. In order to obtain our sample size, we used the 34µmol/L effect size in the three arms, with a level of significance of 5%, power of 85% . The minimal sample size in addition to non-response rate of 20% was 39.
A questionnaire was used to collect demographic data such as sex, gestation age at birth (determined according to the maternal history and Ballard’s scoring system), mode of delivery, birth weight in kilograms, residents, age at enrollment in days, and type of feeding mode. Participants were randomized , then allocated to intervention groups by the research assistants. Simple randomization was performed by drawing a paper from a container containing 45 folded papers: 15 marked ‘FB’ (Fiberoptic BiliBlanket), 15 marked ‘B’ (Bluelight PT) and 15 marked ‘W’ (White light PT). Thus, the choice of the intervention was not according to the preference of the research assistant, nor were they informed about the total serum bilirubin levels of the newborns at the study entry, in order to prevent bias. This was an open label trial whereby both the parent of the participants and the researchers knew which intervention the newborn was receiving.
Before phototherapy initiation, a clinical assessment was done on the newborn, which includes physical examination by a certified clinician; body weighing of the naked newborn |
13 |
Active-Treatment of Control Group |
| Control Group |
White light phototherapy |
The white light PT unit “Atom model PIT- 220 TL”, consists of six white fluorescent bulbs and was placed 35 cm above the newborn with a constant irradiance of 8 µW/cm2/nm. Eye pads were used to prevent damage to the retina. |
Once a newborn’s total serum bilirubin levels reached the threshold phototherapy level on the AAP phototherapy nomogram, phototherapy was initiated.Serum bilirubin reduction rate was measured to monitor response to treatment, this was assessed as the decline in the TSB levels for the duration of exposure to phototherapy, expressed as a percentage of decline per hour. This was monitored through daily (every 24 hours of exposure) sampling of blood for total serum bilirubin. Treatment failure was defined as the need for additional phototherapy units (‘double phototherapy ‘) determined by serial serum bilirubin response while on phototherapy, of which a rise in serum bilirubin level more than 9 μmol /L per hour after phototherapy initiation was an indicator for double phototherapy. Phototherapy was stopped when serum bilirubin levels were <50micromol/l on the AAP nomogram, and treatment duration was then assessed as the duration of time exposure to phototherapy in hours. |
A parallel randomized control trial to test three treatment groups was conducted in the neonatal care unit (NCU) at the Kilimanjaro Christian Medical Centre (KCMC) in Northern Tanzania from January 2019 to May 2019. The NCU has a bed capacity of 62 babies, with an average of 6 enrolled and registered nurses caring for neonates per shift. The babies are nursed in locally made heated cots which use incandescent bulbs to heat up the cot. In our neonatal care unit, phototherapy is the only treatment modality used for unconjugated hyperbilirubinaemia.
65 term neonates (>37 weeks of gestation), less than 7 days of age, admitted with jaundice, were identified by clinicians working in the neonatal unit and screened for eligibility. We included those with hemolytic and non-hemolytic unconjugated hyperbilirubinemia with a total bilirubin level that has reached phototherapy threshold values as per the American Academy of Pediatrics (AAP) nomogram, which is a validated tool used for making decision regarding phototherapy in infants with unconjugated hyperbilirubinemia. Newborns receiving phenobarbitone; newborns with bilirubin levels that have reached exchange transfusion levels on the AAP nomogram; newborns with conjugated hyperbilirubinaemia; newborns who have already received phototherapy prior to enrollment and those whose parents refused to consent were excluded from the study. The study proposal was reviewed and approved by the ethics committee of the Kilimanjaro Christian Medical University College.
Once a newborn’s total serum bilirubin levels reached the threshold phototherapy level on the
AAP phototherapy nomogram, we offered parents or guardians verbal and written information on phototherapy, including all of the following: why phototherapy is being considered, why phototherapy may be needed to treat hyperbilirubinaemia, the possible side effects of phototherapy, the need for eye protection and routine eye care, reassurance that short breaks for feeding, nappy changing and cuddles will be encouraged, and what might happen if phototherapy fails. Detailed explanation of what will happen during phototherapy was also provided: the newborn will be nursed in a supine and prone position unless other clinical conditions prevent this, treatment will be applied to the maximum area of skin, newborn's temperature will be monitored, and the hydration of the newborn will be assessed by daily weighing. Formal consent was obtained from the parent of the study participant. We observed confidentiality of the names of the study participants by using code numbers. We included 41 term neonates who met the inclusion criteria. In order to obtain our sample size, we used the 34µmol/L effect size in the three arms, with a level of significance of 5%, power of 85% . The minimal sample size in addition to non-response rate of 20% was 39.
A questionnaire was used to collect demographic data such as sex, gestation age at birth (determined according to the maternal history and Ballard’s scoring system), mode of delivery, birth weight in kilograms, residents, age at enrollment in days, and type of feeding mode. Participants were randomized , then allocated to intervention groups by the research assistants. Simple randomization was performed by drawing a paper from a container containing 45 folded papers: 15 marked ‘FB’ (Fiberoptic BiliBlanket), 15 marked ‘B’ (Bluelight PT) and 15 marked ‘W’ (White light PT). Thus, the choice of the intervention was not according to the preference of the research assistant, nor were they informed about the total serum bilirubin levels of the newborns at the study entry, in order to prevent bias. This was an open label trial whereby both the parent of the participants and the researchers knew which intervention the newborn was receiving.
Before phototherapy initiation, a clinical assessment was done on the newborn, which includes physical examination by a certified clinician; body weighing of the naked newborn |
15 |
Active-Treatment of Control Group |