| 1. |
- Andersson, Ola, et al.
(författare)
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Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - : a randomized clinical trial
- 2019
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Ingår i: Maternal health, neonatology and perinatology. - : Springer Science and Business Media LLC. - 2054-958X. ; 5:15
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Tidskriftsartikel (refereegranskat)abstract
- Background: Experiments have shown improved cardiovascular stability in lambs if umbilical cord clamping is postponed until positive pressure ventilation is started. Studies on intact cord resuscitation on human term infants are sparse. The purpose of this study was to evaluate differences in clinical outcomes in non-breathing infants between groups, one where resuscitation is initiated with an intact umbilical cord (intervention group) and one group where cord clamping occurred prior to resuscitation (control group).Methods: Randomized controlled trial, inclusion period April to August 2016 performed at a tertiary hospital in Kathmandu, Nepal. Late preterm and term infants born vaginally, non-breathing and in need of resuscitation according to the 'Helping Babies Breathe' algorithm were randomized to intact cord resuscitation or early cord clamping before resuscitation. Main outcome measures were saturation by pulse oximetry (SpO2), heart rate and Apgar at 1, 5 and 10 minutes after birth.Results: At 10 minutes after birth, SpO2 (SD) was significantly higher in the intact cord group compared to the early cord clamping group, 90.4 (8.1) vs 85.4 (2.7) %, P < .001). In the intact cord group, 57 (44%) had SpO2 < 90% after 10 minutes, compared to 93 (100%) in the early cord clamping group, P < 0.001. SpO2 was also significantly higher in the intervention (intact cord) group at one and five minutes after birth. Heart rate was lower in the intervention (intact cord) group at one and five minutes and slightly higher at ten minutes, all significant findings. Apgar score was significantly higher at one, five and ten minutes. At 5 minutes, 23 (17%) had Apgar score < 7 in the intervention (intact cord) group compared to 26 (27%) in the early cord clamping group, P < .07. Newborn infants in the intervention (intact cord) group started to breathe and establish regular breathing earlier than in the early cord clamping group.Conclusions: This study provides new and important information on the effects of resuscitation with an intact umbilical cord. The findings of improved SpO2 and higher Apgar score, and the absence of negative consequences encourages further studies with longer follow-up.Trial registration: Clinicaltrials.gov NCT02727517, 2016/4/4.
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| 2. |
- Day, Louise T., et al.
(författare)
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"Every Newborn-BIRTH" protocol : observational study validating indicators for coverage and quality of maternal and newborn health care in Bangladesh, Nepal and Tanzania
- 2019
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Ingår i: Journal of Global Health. - : International Global Health Society. - 2047-2978 .- 2047-2986. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: To achieve Sustainable Development Goals and Universal Health Coverage, programmatic data are essential. The Every Newborn Action Plan, agreed by all United Nations member states and >80 development partners, includes an ambitious Measurement Improvement Roadmap. Quality of care at birth is prioritised by both Every Newborn and Ending Preventable Maternal Mortality strategies, hence metrics need to advance from health service contact alone, to content of care. As facility births increase, monitoring using routine facility data in DHIS2 has potential, yet validation research has mainly focussed on maternal recall surveys. The Every Newborn - Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aims to validate selected newborn and maternal indicators for routine tracking of coverage and quality of facility-based care for use at district, national and global levels.Methods: EN-BIRTH is an observational study including >20000 facility births in three countries (Tanzania, Bangladesh and Nepal) to validate selected indicators. Direct clinical observation will be compared with facility register data and a pre-discharge maternal recall survey for indicators including: uterotonic administration, immediate newborn care, neonatal resuscitation and Kangaroo mother care. Indicators including neonatal infection management and antenatal corticosteroid administration, which cannot be easily observed, will be validated using inpatient records. Trained clinical observers in Labour/Delivery ward, Operation theatre, and Kangaroo mother care ward/areas will collect data using a tablet-based customised data capturing application. Sensitivity will be calculated for numerators of all indicators and specificity for those numerators with adequate information. Other objectives include comparison of denominator options (ie, true target population or surrogates) and quality of care analyses, especially regarding intervention timing. Barriers and enablers to routine recording and data usage will be assessed by data flow assessments, quantitative and qualitative analyses.Conclusions: To our knowledge, this is the first large, multi-country study validating facility-based routine data compared to direct observation for maternal and newborn care, designed to provide evidence to inform selection of a core list of indicators recommended for inclusion in national DHIS2. Availability and use of such data are fundamental to drive progress towards ending the annual 5.5 million preventable stillbirths, maternal and newborn deaths.
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| 3. |
- Day, Louise T, et al.
(författare)
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"Every Newborn-BIRTH" protocol: observational study validating indicators for coverage and quality of maternal and newborn health care in Bangladesh, Nepal and Tanzania.
- 2019
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Ingår i: Journal of global health. - : International Global Health Society. - 2047-2986 .- 2047-2978. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- To achieve Sustainable Development Goals and Universal Health Coverage, programmatic data are essential. The Every Newborn Action Plan, agreed by all United Nations member states and >80 development partners, includes an ambitious Measurement Improvement Roadmap. Quality of care at birth is prioritised by both Every Newborn and Ending Preventable Maternal Mortality strategies, hence metrics need to advance from health service contact alone, to content of care. As facility births increase, monitoring using routine facility data in DHIS2 has potential, yet validation research has mainly focussed on maternal recall surveys. The Every Newborn - Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aims to validate selected newborn and maternal indicators for routine tracking of coverage and quality of facility-based care for use at district, national and global levels.EN-BIRTH is an observational study including >20 000 facility births in three countries (Tanzania, Bangladesh and Nepal) to validate selected indicators. Direct clinical observation will be compared with facility register data and a pre-discharge maternal recall survey for indicators including: uterotonic administration, immediate newborn care, neonatal resuscitation and Kangaroo mother care. Indicators including neonatal infection management and antenatal corticosteroid administration, which cannot be easily observed, will be validated using inpatient records. Trained clinical observers in Labour/Delivery ward, Operation theatre, and Kangaroo mother care ward/areas will collect data using a tablet-based customised data capturing application. Sensitivity will be calculated for numerators of all indicators and specificity for those numerators with adequate information. Other objectives include comparison of denominator options (ie, true target population or surrogates) and quality of care analyses, especially regarding intervention timing. Barriers and enablers to routine recording and data usage will be assessed by data flow assessments, quantitative and qualitative analyses.To our knowledge, this is the first large, multi-country study validating facility-based routine data compared to direct observation for maternal and newborn care, designed to provide evidence to inform selection of a core list of indicators recommended for inclusion in national DHIS2. Availability and use of such data are fundamental to drive progress towards ending the annual 5.5 million preventable stillbirths, maternal and newborn deaths.
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| 4. |
- KC, Ashish, 1982-, et al.
(författare)
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Effect of early versus delayed cord clamping in neonate on heart rate, breathing and oxygen saturation during first 10 minutes of birth : randomized clinical trial
- 2019
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Ingår i: Maternal health, neonatology and perinatology. - : Springer Science and Business Media LLC. - 2054-958X. ; 5
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Tidskriftsartikel (refereegranskat)abstract
- Background: Delayed cord clamping (DCC) after 180 s reduces iron deficiency up to 8 months of infancy compared to babies who received Early Cord Clamping (ECC) at less than 60 s. Experimentally DCC has shown to improve cardio-vascular stability. To evaluate the effect of delayed (≥180 s) group versus early (≤60 s) cord clamping group on peripheral blood oxygenation and heart rate up to 10 min after birth on term and late preterm infants.Methods: We conducted a single centred randomized clinical trial in a low risk delivery unit in tertiary Hospital, Nepal. One thousand five hundred ten women, low risk vaginal delivery with foetal heart rate (FHR) ≥ 100 ≤ 160 beats per minute (bpm) and gestational age (≥33 weeks) were enrolled in the study. Participants were randomly assigned to cord clamped ≤60 s of birth and ≥ 180 s. The main outcome measures were oxygen saturation, heart rate from birth to 10 min and time of spontaneous breathing. The oxygen saturation and heart rate, the time of first breath and establishment of regular breathing was analysed using Student t-test to compare groups. We analysed the range of heart rate distributed by different centiles from the time of birth at 30 s intervals until 10 min.Results: The oxygen saturation was 18% higher at 1 min, 13% higher at 5 min and 10% higher at 10 min in babies who had cord clamping in delayed group compared to early group (p < 0.001). The heart rate was 9 beats lower at 1 min and3 beats lower at 5 min in delayed group compared to early group (p < 0.001). Time of first breath and regular breathing was established earlier in babies who had cord clamping at 180 s or more.Conclusion: Spontaneously breathing babies subjected to DCC have higher oxygen saturation up to 10 min after birth compared to those who have undergone ECC. Spontaneously breathing babies with DCC have lower heart rates compared to ECC until 390 s. Spontaneously breathing babies receiving DCC have early establishment of breathing compared to ECC.Trial registration: ISRCTN, 5 April 2016.
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| 5. |
- Kc, Ashish, 1982-, et al.
(författare)
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Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants : a facility-based, randomized-controlled trial in Nepal.
- 2016
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Ingår i: BMC Pediatrics. - : Springer Science and Business Media LLC. - 1471-2431. ; 16
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Delayed cord clamping at birth has shown to benefit neonates with increased placental transfusion leading to higher haemoglobin concentrations, additional iron stores and less anaemia later in infancy, higher red blood cell flow to vital organs and better cardiopulmonary adaptation. As iron deficiency in infants even without anaemia has been associated with impaired development, delayed cord clamping seems to benefit full term infants also in regions with a relatively low prevalence of iron deficiency anaemia. In Nepal, there is a high anaemia prevalence among children between 6 and 17 months (72-78 %). The objective of the proposed study is to evaluate the effects of delayed and early cord clamping on anaemia (and haemoglobin level) at 8 and 12 months, ferritin at 8 and 12 months, bilirubin at 2-3 days, admission to Neonatal Intensive Care Unit (NICU) or special care nursery, and development at 12 and 18-24 months of age.METHODS/DESIGN: A randomized, controlled trial comparing delayed and early cord clamping will be implemented at Paropakar Maternity and Women's Hospital in Kathmandu, Nepal. Pregnant woman of gestational age 34-41 weeks who deliver vaginally will be included in the study. The interventions will consist of delayed clamping of the umbilical cord (≥180 s after delivery) or early clamping of the umbilical cord (≤60 s). At 8 and 12 months of age, infant's iron status and developmental milestones will be measured.DISCUSSION: This trial is important to perform because, although strong indications for the beneficial effect of delayed cord clamping on anaemia at 8 to 12 months of age exist, it has not yet been evaluated by a randomized trial in this setting. The proposed study will analyse both outcome as well as safety effects. Additionally, the results may not only contribute to practice in Nepal, but also to the global community, in particular to other low-income countries with a high prevalence of iron deficiency anaemia.
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| 6. |
- KC, Ashish, 1982-, et al.
(författare)
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Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months : A Randomized Clinical Trial
- 2017
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Ingår i: JAMA pediatrics. - : American Medical Association (AMA). - 2168-6203 .- 2168-6211. ; 171:3, s. 264-270
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Tidskriftsartikel (refereegranskat)abstract
- Importance: Delayed umbilical cord clamping has been shown to improve iron stores in infants to 6 months of age. However, delayed cord clamping has not been shown to prevent iron deficiency or anemia after 6 months of age.Objective: To investigate the effects of delayed umbilical cord clamping, compared with early clamping, on hemoglobin and ferritin levels at 8 and 12 months of age in infants at high risk for iron deficiency anemia.Design, Setting, and Participants: This randomized clinical trial included 540 late preterm and term infants born vaginally at a tertiary hospital in Kathmandu, Nepal, from October 2 to November 21, 2014. Follow-up included blood levels of hemoglobin and ferritin at 8 and 12 months of age. Follow-up was completed on December 11, 2015. Analysis was based on intention to treat.Interventions: Infants were randomized to delayed umbilical cord clamping (≥180 seconds after delivery) or early clamping (≤60 seconds after delivery).Main Outcomes and Measures: Main outcomes included hemoglobin and anemia levels at 8 months of age with the power estimate based on the prevalence of anemia. Secondary outcomes included hemoglobin and anemia levels at 12 months of age and ferritin level, iron deficiency, and iron deficiency anemia at 8 and 12 months of age.Results: In this study of 540 infants (281 boys [52.0%] and 259 girls [48.0%]; mean [SD] gestational age, 39.2 [1.1] weeks), 270 each were randomized to the delayed and early clamping groups. At 8 months of age, 212 infants (78.5%) from the delayed group and 188 (69.6%) from the early clamping group returned for blood sampling. After multiple imputation analysis, infants undergoing delayed clamping had higher levels of hemoglobin (10.4 vs 10.2 g/dL; difference, 0.2 g/dL; 95% CI, 0.1 to 0.4 g/dL). Delayed cord clamping also reduced the prevalence of anemia (hemoglobin level <11.0 g/dL) at 8 months in 197 (73.0%) vs 222 (82.2%) infants (relative risk, 0.89; 95% CI, 0.81-0.98; number needed to treat [NNT], 11; 95% CI, 6-54). At 8 months, the risk for iron deficiency was reduced in the delayed clamping group in 60 (22.2%) vs 103 (38.1%) patients (relative risk, 0.58; 95% CI, 0.44-0.77; NNT, 6; 95% CI, 4-13). At 12 months, delayed cord clamping still resulted in a hemoglobin level of 0.3 (95% CI, 0.04-0.5) g/dL higher than in the early cord clamping group and a relative risk for anemia of 0.91 (95% CI, 0.84-0.98), resulting in a NNT of 12 (95% CI, 7-78).Conclusions and Relevance: Delayed cord clamping reduces anemia at 8 and 12 months of age in a high-risk population, which may have major positive effects on infants' health and development.Trial Registration: clinicaltrials.gov Identifier: NCT02222805.
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| 7. |
- Nelin, Viktoria, et al.
(författare)
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Factors associated with timing of umbilical cord clamping in tertiary hospital of Nepal.
- 2018
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Ingår i: BMC Research Notes. - : Springer Science and Business Media LLC. - 1756-0500. ; 11:1
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Delayed umbilical cord clamping (DCC) (≥ 60 s) is recognized to improve iron status and neurodevelopment compared to early umbilical cord clamping. The aim of this study is to identify current umbilical cord clamping practice and factors determining the timing of clamping in a low-resource setting where prevalence of anemia in infants is high.RESULTS: A cross-sectional study design including 128 observations of clinical practice in a tertiary-level maternity hospital in Kathmandu, Nepal. Overall 48% of infants received DCC. The mean and median cord clamping times were 61 ± 33 and 57 (38-79) s, respectively. Univariate analysis showed that infants born during the night shift were five times more likely to receive DCC (OR 5.6, 95% CI 1.4-38.0). Additionally, infants born after an obstetric complication were 2.5 times more likely to receive DCC (OR 2.5, 95% CI 1.2-5.3), and babies requiring ventilation had a 65% lower likelihood of receiving DCC (OR 0.35, 95% CI 0.13-0.88). Despite the existence of standard protocols for cord clamping and its proven benefit, the lack of uniformity in the timing of cord clamping reveals poor translation of clinical guidelines into clinical practice. Clinical trial registration ISRCTN97846009.
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| 8. |
- Nelin, Viktoria, et al.
(författare)
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Factors associated with timing of umbilical cord clamping in tertiary hospital of Nepal.
- 2018
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Ingår i: BMC research notes. - : Springer Science and Business Media LLC. - 1756-0500. ; 11:1
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Tidskriftsartikel (refereegranskat)abstract
- Delayed umbilical cord clamping (DCC) (≥ 60 s) is recognized to improve iron status and neurodevelopment compared to early umbilical cord clamping. The aim of this study is to identify current umbilical cord clamping practice and factors determining the timing of clamping in a low-resource setting where prevalence of anemia in infants is high.A cross-sectional study design including 128 observations of clinical practice in a tertiary-level maternity hospital in Kathmandu, Nepal. Overall 48% of infants received DCC. The mean and median cord clamping times were 61 ± 33 and 57 (38-79) s, respectively. Univariate analysis showed that infants born during the night shift were five times more likely to receive DCC (OR 5.6, 95% CI 1.4-38.0). Additionally, infants born after an obstetric complication were 2.5 times more likely to receive DCC (OR 2.5, 95% CI 1.2-5.3), and babies requiring ventilation had a 65% lower likelihood of receiving DCC (OR 0.35, 95% CI 0.13-0.88). Despite the existence of standard protocols for cord clamping and its proven benefit, the lack of uniformity in the timing of cord clamping reveals poor translation of clinical guidelines into clinical practice. Clinical trial registration ISRCTN97846009.
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| 9. |
- Rana, Nisha, 1979-
(författare)
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Delayed cord clamping in Nepal-Evidence for implementation
- 2019
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The aims of this thesis were to investigate effects of timing of umbilical cord clamping on newborn health, and on infant outcomes up to 12 months of age in a high-risk population and to explore the context of implementing changed umbilical cord clamping practices in Nepal.A randomised controlled trial with 540 late preterm and term infants born by normal vaginal delivery was set up at a maternity hospital in Kathmandu, Nepal. Infants were enrolled in two parallel groups (1:1 ratio), randomised to early (ECC) (≤60 seconds) or delayed cord clamping (DCC) (≥180 seconds).To get a deeper understanding of barriers and enablers for change in clinical practise in relation to cord clamping, a qualitative study with delivery staff was set up. Focus group discussions and key informant interviews were conducted at two major delivery hospitals in Kathmandu.Paper I showed that DCC was an effective intervention to reduces anaemia at 8 and 12 months of age in a high-risk population, which may have major positive effects on infants’ health and development.Paper II utilised the Ages and Stages Questionnaire (ASQ) to assess neurodevelopment in infants at 12 months of age. The result showed DCC was associated with an improvement of the overall neurodevelopment at 12 months of age as compared to infants in the ECC group.Paper III showed that DCC was not associated with an increased risk of hyperbilirubinemia during the first day of life or risk of jaundice within 4 weeks compared with the ECC group.Paper IV demonstrated how a positive attitude towards DCC and a will to rely on research evidence when striving to do good are facilitators of change in clinical practice. However, the participants in the study were hesitant to apply DCC due to lack of national or institutional protocols and formal training. Consequently, they were forced to take informal decisions and rely on alternate sources of information.In conclusion, delaying umbilical cord clamping for 180 seconds is safe and associated with a significantly reduced risk of anaemia at 8 and 12 months which may have neurodevelopmental effects at a later age and is not associated with an increased risk of hyperbilirubinemia during the first days of life or risk of jaundice within 4 weeks of age. In order to change cord clamping practices to comply with evidence and policies health-care staff needs to be better supported by the governance structures of the health system, with clear and approved guidelines made available and coherent training and support.
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| 10. |
- Rana, Nisha, 1979-, et al.
(författare)
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Delayed cord clamping was not associated with an increased risk of hyperbilirubinaemia on the day of birth or jaundice in the first 4 weeks
- 2020
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Ingår i: Acta Paediatrica. - Sweden : Wiley. - 0803-5253 .- 1651-2227. ; 109:1, s. 71-77
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Tidskriftsartikel (refereegranskat)abstract
- Aim: Our aim was to investigate the effects of timing of cord clamping on the risk of hyperbilirubinaemia.Methods: We recruited 540 normal vaginal deliveries at the Paropakar Maternity and Women’s Hospital in Kathmandu, Nepal, from October 2 to November 21, 2014. They were randomised into two groups: 257/270 were cord clamped within 60 sec‐ onds and 209/270 after 180 seconds. Transcutaneous bilirubin was measured at discharge and 24 hours. At 4 weeks, 506 mothers were successfully contacted by phone, and the health status of the baby and their history of jaundice and treatment was recorded.Results: Based on transcutaneous bilirubin at discharge, 22/261 (8.4%) in the early group and 25/263 (9.5%) in the delayed group (P = 0.76) were at high risk of subse‐ quent hyperbilirubinemia. At the 4‐week follow‐up, jaundice was reported in 13/253 (5.1%) in the early and 17/253 (6.7%) in the delayed group (P = 0.57) and 3/253 (1.2 %) of the early and 1/253 (0.4%) of the delayed group (P = 0.62) received treatment. All analyses were based on intention‐to‐treat.Conclusion: Delayed cord clamping was not associated with an increased risk of hy‐ perbilirubinaemia during the first day of life or risk of jaundice within 4 weeks com‐ pared with the early group.
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