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Community-Based Cluster Randomized Controlled Trial: Empowering Households to Identify and Provide Appropriate Care for Low-Birthweight Newborns in Nepal
Stephen Hodgins
University of Alberta
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8365-3311
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Public Health.
Background: Most newborn deaths occur among those of low birthweight (LBWt), due to prematurity &/or impaired fetal growth. Simple practices can substantially mitigate this risk. In low-income country settings where many births occur at home, strategies are needed that empower mothers to determine if their babies are higher risk and take measures to reduce risk. Earlier studies suggest that foot-length may be a good proxy for birthweight. An earlier Nepal study found a 6.9cm cut-off performed relatively well, differentiating normal from low birthweight.
Methods: Community-based, cluster-randomized controlled trial. Objective: to determine whether family-administered screening, associated with targeted messages improves care practices known to mitigate LBWt-associated risks. Participants: women participating in a parent trial in rural Nepal, recruited late in pregnancy. Women were given a 6.9cm card to assess whether the baby’s foot is small; if so, to call a number on the card for advice. Follow-up visits were made over the 2 weeks following the birth, assessing for 2 behavioral outcomes: reported skin-to-skin thermal care, and care-seeking outside the home; assessed restricting to low birthweight (using 2 cutoffs: 2,500g and 2,000g). Randomization: 17 clusters intervention, 17 control.
The study also documented performance along the presumed causal chain from intervention through behavioral impact.
Results: 2,022 intervention, 2,432 control. Intervention arm: 519 had birthweight <2,500g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls). No significant difference found on care-seeking; for those <2,500g RR 1.13 (95%CI: 0.97-1.131). A higher proportion of those in the intervention arm reported skin-to-skin thermal care than among controls; for those <2,500g RR 2.50 (95%CI: 2.01-3.1). However, process measures suggest this apparent effect cannot be attributed to the intervention; the card performed poorly as a proxy for LBWt, misclassifying 84.5% of those <2,000 as normal.
Conclusions: Although the trial found an apparent effect on one of the behavioral outcomes, this cannot be attributed to the intervention; most likely it was a result of pure chance. Other approaches are needed for identifying small, at-risk babies in such settings, and targeting them for appropriate care messaging.
Trial registration: https://clinicaltrials.gov/ct2/show/NCT02802332, registered 6/16/2016.
Keywords
low birth-weight, thermal care, care-seeking, anthropometry, home childbirth, behavior change, sensitivity and specificity, low- and middle-income countries.
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CURRENT STATUS: Published
Version 2
Posted 01 Jun, 2020
Published
On 24 Aug, 2020
No community comments so far
Review #2 received
Received 22 Jun, 2020
Reviewer #2 agreed
On 12 Jun, 2020
Review #1 received
Received 28 May, 2020
Reviewers invited
Invitations sent on 22 May, 2020
Reviewer #1 agreed
On 22 May, 2020
Editor assigned
On 21 May, 2020
Submission checks complete
On 20 May, 2020
Editor invited
On 20 May, 2020
No comments provided
Editorial decision: Major revision
On 12 May, 2020
Review #2 received
Received 14 Mar, 2020
Review #1 received
Received 04 Mar, 2020
Reviewer #2 agreed
On 29 Feb, 2020
Reviewer #1 agreed
On 26 Feb, 2020
Reviewers invited
Invitations sent on 12 Feb, 2020
Editor assigned
On 27 Jan, 2020
Submission checks complete
On 26 Jan, 2020
Editor invited
On 26 Jan, 2020
First submitted
On 24 Jan, 2020
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This preprint is under consideration at BMC Public Health. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Community-Based Cluster Randomized Controlled Trial: Empowering Households to Identify and Provide Appropriate Care for Low-Birthweight Newborns in Nepal
Stephen Hodgins
University of Alberta
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8365-3311
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 01 Jun, 2020
Published
On 24 Aug, 2020
No community comments so far
Review #2 received
Received 22 Jun, 2020
Reviewer #2 agreed
On 12 Jun, 2020
Review #1 received
Received 28 May, 2020
Reviewers invited
Invitations sent on 22 May, 2020
Reviewer #1 agreed
On 22 May, 2020
Editor assigned
On 21 May, 2020
Submission checks complete
On 20 May, 2020
Editor invited
On 20 May, 2020
No comments provided
Editorial decision: Major revision
On 12 May, 2020
Review #2 received
Received 14 Mar, 2020
Review #1 received
Received 04 Mar, 2020
Reviewer #2 agreed
On 29 Feb, 2020
Reviewer #1 agreed
On 26 Feb, 2020
Reviewers invited
Invitations sent on 12 Feb, 2020
Editor assigned
On 27 Jan, 2020
Submission checks complete
On 26 Jan, 2020
Editor invited
On 26 Jan, 2020
First submitted
On 24 Jan, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Public Health.
Background: Most newborn deaths occur among those of low birthweight (LBWt), due to prematurity &/or impaired fetal growth. Simple practices can substantially mitigate this risk. In low-income country settings where many births occur at home, strategies are needed that empower mothers to determine if their babies are higher risk and take measures to reduce risk. Earlier studies suggest that foot-length may be a good proxy for birthweight. An earlier Nepal study found a 6.9cm cut-off performed relatively well, differentiating normal from low birthweight.
Methods: Community-based, cluster-randomized controlled trial. Objective: to determine whether family-administered screening, associated with targeted messages improves care practices known to mitigate LBWt-associated risks. Participants: women participating in a parent trial in rural Nepal, recruited late in pregnancy. Women were given a 6.9cm card to assess whether the baby’s foot is small; if so, to call a number on the card for advice. Follow-up visits were made over the 2 weeks following the birth, assessing for 2 behavioral outcomes: reported skin-to-skin thermal care, and care-seeking outside the home; assessed restricting to low birthweight (using 2 cutoffs: 2,500g and 2,000g). Randomization: 17 clusters intervention, 17 control.
The study also documented performance along the presumed causal chain from intervention through behavioral impact.
Results: 2,022 intervention, 2,432 control. Intervention arm: 519 had birthweight <2,500g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls). No significant difference found on care-seeking; for those <2,500g RR 1.13 (95%CI: 0.97-1.131). A higher proportion of those in the intervention arm reported skin-to-skin thermal care than among controls; for those <2,500g RR 2.50 (95%CI: 2.01-3.1). However, process measures suggest this apparent effect cannot be attributed to the intervention; the card performed poorly as a proxy for LBWt, misclassifying 84.5% of those <2,000 as normal.
Conclusions: Although the trial found an apparent effect on one of the behavioral outcomes, this cannot be attributed to the intervention; most likely it was a result of pure chance. Other approaches are needed for identifying small, at-risk babies in such settings, and targeting them for appropriate care messaging.
Trial registration: https://clinicaltrials.gov/ct2/show/NCT02802332, registered 6/16/2016.
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Figure 2
Figure 3
Figure 4
Figure 5
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