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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
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för kvinnors och barns hälsa, Internationell mödra- och barnhälsovård (IMCH), Internationell barnhälsa och nutrition. Health Section, United Nations Children’s Fund (UNICEF), Lalitpur, Nepal; Paropakar Maternity and Women’s Hospital, Kathmandu, Nepal. (Internationell barnhälsa och nutrition)ORCID-id: 0000-0002-0541-4486
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för kvinnors och barns hälsa, Internationell mödra- och barnhälsovård (IMCH), Internationell barnhälsa och nutrition. Paropakar Maternity and Women’s Hospital, Kathmandu, Nepal. (Internationell barnhälsa och nutrition)
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för kvinnors och barns hälsa, Internationell mödra- och barnhälsovård (IMCH), Internationell barnhälsa och nutrition. (Internationell barnhälsa och nutrition)
epartment of Pediatrics, Hospital of Halland, Halmstad, Sweden.
Visa övriga samt affilieringar
2017 (Engelska)Ingår i: JAMA pediatrics, ISSN 2168-6203, E-ISSN 2168-6211, Vol. 171, nr 3, s. 264-270Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

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.

Ort, förlag, år, upplaga, sidor
2017. Vol. 171, nr 3, s. 264-270
Nationell ämneskategori
Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi
Identifikatorer
URN: urn:nbn:se:uu:diva-329087DOI: 10.1001/jamapediatrics.2016.3971ISI: 000396202400017PubMedID: 28114607OAI: oai:DiVA.org:uu-329087DiVA, id: diva2:1139582
Forskningsfinansiär
Svenska läkaresällskapetTillgänglig från: 2017-09-08 Skapad: 2017-09-08 Senast uppdaterad: 2019-03-25Bibliografiskt granskad
Ingår i avhandling
1. Delayed cord clamping in Nepal-Evidence for implementation
Öppna denna publikation i ny flik eller fönster >>Delayed cord clamping in Nepal-Evidence for implementation
2019 (Engelska)Doktorsavhandling, sammanläggning (Övrigt vetenskapligt)
Abstract [en]

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.

Ort, förlag, år, upplaga, sidor
Uppsala: Acta Universitatis Upsaliensis, 2019. s. 66
Serie
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1557
Nyckelord
Attitude, Clinical Practice, Ferritin, Haemoglobin, Iron deficiency, Iron deficiency anaemia, Iron status, Jaundice, Neonatal hyperbilirubinemia, Newborn, Neurodevelopment, Randomized controlled trial, Umbilical cord clamping.
Nationell ämneskategori
Medicin och hälsovetenskap
Forskningsämne
Medicinsk vetenskap
Identifikatorer
urn:nbn:se:uu:diva-379616 (URN)978-91-513-0611-7 (ISBN)
Disputation
2019-05-22, Rudbeckssalen, Akademiska sjukhuset, Rudbeck entréplan, C11, Uppsala, 09:15 (Engelska)
Opponent
Handledare
Forskningsfinansiär
Vetenskapsrådet, 2014-04229Stiftelsen för internationalisering av högre utbildning och forskning (STINT), PT2016-6639
Tillgänglig från: 2019-04-26 Skapad: 2019-03-25 Senast uppdaterad: 2019-06-18

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KC, AshishRana, NishaMålqvist, MatsAndersson, Ola

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