Infant, Low Birth WeightPhase 3NCT01455636
Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
A Phase 3 study testing Hand Sanitizer, Improved Micronutrient Powder and No hand sanitizer in people with Infant, Low Birth Weight, run by The Hospital for Sick Children at 2 sites in 2 countries.
Trial summary
Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimately micronutrient deficiencies that result in post-natal linear growth faltering. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Low Birth Weight
- What is being tested?
- Hand Sanitizer, Improved Micronutrient Powder and No hand sanitizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 467 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2010to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- infants born as singletons and full term (mothers will be identified at ~8 months or >37 weeks gestation to avoid including premature babies who are at high risk of neonatal mortality).
- must have a birth weight ≥1800g and <2500g.
- Families involved in the study must be planning to remain in the study community for the next 12 months
- written consent must be received from an authorized guardian.
- all pregnant women will be identified and visited during their 8th month of pregnancy. A local informant will be identified for birth notification, who will inform the CHW (with a cell phone) when a child is born. All newborns will be screened and those who meet the inclusion criteria will be enrolled.
Who cannot join
- newborns with severe illnesses or congenital abnormalities /severe malformations that affect feeding will be excluded from the study.
- infants whose mothers did not survive during childbirth will be excluded.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial
Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimately micronutrient deficiencies that result in post-natal linear growth faltering. The objective of this study is to facilitate improved feeding practices through the early reduction of infections using the innovative tools of water-based hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning at 6 months of age). A community-based cluster randomized controlled trial will be carried out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of the children in each group will be randomized to receive I-MNP. All groups will receive nutrition and hygiene education from birth to 12 months. Recumbent length is the primary outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity to translate the results directly and quickly into child health programs in Bangladesh.
Read the detailed description
General Objective To explore the relative effect of hand sanitizer and home fortification with an improved MNP (plus nutrition education) to prevent infections, improve feeding and ultimately to improve growth among LBW infants in Bangladesh.
Specific Objectives Although the applicants clearly understand that the primary purpose of the Alive and Thrive RFP is to improve infant feeding, we believe that by preventing infections, feeding will improve and growth will accelerate. Thus our primary objective is to determine the relative effect of intervention packages to improve feeding and thus prevent or reverse linear growth faltering and reduce rates of stunting among LBW infants (Ha: Combination of all three interventions will improve feeding and prevent or reverse linear growth faltering and reduce rates of stunting)
Secondary objectives (i) Investigate the effect of intervention packages on rates of diarrhea and acute respiratory tract infection (ARI).
(Ha: Combination of all three interventions will reduce on rates of diarrhea and acute respiratory tract infection) (ii) Explore the effect of the intervention packages on energy and nutrient intakes of infants and their feeding behaviors.
(Ha: Combination of all three interventions will increase energy and nutrient intakes of infants and improve the feeding behaviors) (iii) Determine the impact of the improved MNP on iron status (hemoglobin level in blood) in a subgroup.
(Ha: The group receiving the improved MNP will have increased hemoglobin level in blood and reduced rates of anemia)
- Conditions
- Infant, Low Birth Weight
- Being tested
- Hand Sanitizer, Improved Micronutrient Powder, No hand sanitizer, No Micronutrient Powder
- Keywords
- pediatric, micronutrient powder, hand hygiene, low birth weight, infant feeding, hand sanitizers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand SanitizerOther
The water-based hand sanitizer to be used in the current project will be produced in India by Hexagon Inc. It will be dispensed via a foam dispenser, since it has been established that foam is preferable to gel because of the natural tendency to rub foam more thoroughly into one's hands.
Improved Micronutrient PowderDietary supplement
Also called MNP
A modified and improved formulation of MNPs will be used. The composition is specially designed to enhance appetite and growth with 17 essential micronutrients; including calcium and magnesium, as well as an increased amount of zinc (10 mg). Previously MNP formulations (including the UNICEF formulation) contained only 5 mg of zinc and did not contain magnesium and calcium, which are essential nutrients for bone formation.
No hand sanitizerOther
All family members will receive hand-hygiene education with Information, Education and Communication (IEC) materials including pictorial messages describing critical points for hand-hygiene.
No placebo for the hand sanitizers will be provided to families in Groups 3 and 4 because it would be unethical if families were to use an inactive hand-hygiene product as a substitute for routine hand-washing. Nevertheless, all groups will be instructed
No Micronutrient PowderDietary supplement
I-MNP and placebo will be procured from a local pharmaceutical company in Dhaka, Bangladesh (Renata Pharma Ltd.). The outer-packaging of the sachets of 'I-MNP' and 'placebo-MNP' will be identical except for a different numeric code for each.
| Study group | Role | What they receive |
|---|---|---|
| Hand hygiene with Hand Sanitizer (HS) | Experimental | To obtain 480 low birth weight infants the entire area of Kaliganj and Norsinghdi will be divided into 48 clusters based on the list of pregnant women identified through a household survey.
24 clusters will be randomized to receive Hand Sanitizer plus nutrition and hygiene education and the remaining 24 will receive only nutrition and hygiene education. Receives: Other: Hand Sanitizer |
| Hand hygiene with no Hand Sanitizer | Experimental | To obtain 480 low birth weight infants the entire area of Kaliganj and Norsinghdi will be divided into 48 clusters based on the list of pregnant women identified through a household survey.
24 clusters will be randomized to receive Hand Sanitizer plus nutrition and hygiene education and the remaining 24 will receive only nutrition and hygiene education. Receives: Other: Hand Sanitizer; Dietary Supplement: Improved Micronutrient Powder |
| Micronutrient Powder | Experimental | From 6 months of age, children in randomized clusters will be assigned to receive one sachet of Improved Micronutrient Powder, I-MNP per day for six months with or without hand sanitizer.
Throughout the entire intervention period, mothers/caregivers of the children in all groups will receive simple, standardized, and age and culturally appropriate nutrition and health education that aims to improve feeding and health-seeking behavior and caring practices. Receives: Dietary Supplement: Improved Micronutrient Powder; Dietary Supplement: No Micronutrient Powder |
| Control | Placebo comparator | From 6 months of age, children in randomized clusters will be assigned to receive no hand sanitizer or no micronutrient powder
Throughout the entire intervention period, mothers/caregivers of the children in all groups will receive simple, standardized, and age and culturally appropriate nutrition and health education that aims to improve feeding and health-seeking behavior and caring practices. Receives: Other: No hand sanitizer; Dietary Supplement: No Micronutrient Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry - Recumbent Length
Recumbent length will be measured to 0.01cm on a locally constructed wooden stadiometer. Anthropometric data will be converted to Z-scores using the WHO growth standards.
Measured: Change from baseline in length over 12 months
Anthropometry - Weight
weight using an infant balance with 15 g precision (SECA Model 345) calibrated on a regular, scheduled basis. Anthropometric data will be converted to Z-scores using the WHO growth standards.
Measured: Change from baseline in weight over 12 months
Secondary outcomes (5)
Infectious Morbidity
Diarrhea will be defined as >3 loose stools in a 24-h period or >1 loose stool containing blood. Mothers are expected to use ORS and zinc tablets for all diarrhea episodes (provided free to study subjects irrespective of study group). Acute Respiratory Infections (ARI) will be diagnosed according to World Health Organization Criteria Information on the occurrence, type and severity of diarrhea and ARI and health seeking be collected weekly.
Measured: Weekly for 52 weeks
Infant and young child feeding
Information on age-specific feeding practices will be obtained monthly by trained nutritionists using standardized infant and young child feeding indicators.
Measured: Monthly for 12 months
Blood collection and Hemoglobin (Hb) measurement
A standardized finger-prick technique will be used to collect blood from the infants from a subsample of Groups 2 and 4 (at 6 and 12 months). Hb will be measured using a portable Hemocue (Hemocue Inc.).
Measured: 6 and 12 months post randomization
Socioeconomic status (SES) and demographic information
Household SES will be assessed by a pre-coded structured interview designed to obtain information on the household demographic structure, parental education, employment, material possessions and by inspection of housing quality.
Measured: Baseline
Household Food Security
Information on household food security will be collected using standardized questionnaires used in the same population.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJun 2010
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, Low Birth WeightStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Zlotkin, The Hospital for Sick Children
- Investigators
- Stanley Zlotkin, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455636
- Sponsor's protocol ID
- 1000014576
- Status last verified
- Jun 2015
- First submitted
- 16 Oct 2011
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shafique S, Sellen DW, Lou W, Jalal CS, Jolly SP, Zlotkin SH. Mineral- and vitamin-enhanced micronutrient powder reduces stunting in full-term low-birth-weight infants receiving nutrition, health, and hygiene education: a 2 x 2 factorial, cluster-randomized trial in Bangladesh. Am J Clin Nutr. 2016 May;103(5):1357-69. doi: 10.3945/ajcn.115.117770. Epub 2016 Apr 6.
PubMed 27053383Singla DR, Shafique S, Zlotkin SH, Aboud FE. A 22-element micronutrient powder benefits language but not cognition in Bangladeshi full-term low-birth-weight children. J Nutr. 2014 Nov;144(11):1803-10. doi: 10.3945/jn.114.193094. Epub 2014 Aug 20.
PubMed 25143374
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01455636
- Acronym / sponsor ID
- 1000014576
- Conditions
- Infant, Low Birth Weight
- Keywords
- pediatric, micronutrient powder, hand hygiene, low birth weight, infant feeding, hand sanitizers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimately micronutrient deficiencies that result in post-natal linear growth faltering. The objective of this study is to facilitate improved feeding practices through the early reduction of infections using the innovative tools of water-based hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning at 6 months of age). A community-based cluster randomized controlled trial will be carried out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of the children in each group will be randomized to receive I-MNP. All groups will receive nutrition and hygiene education from birth to 12 months. Recumbent length is the primary outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity to translate the results directly and quickly into child health programs in Bangladesh.
Detailed description
General Objective To explore the relative effect of hand sanitizer and home fortification with an improved MNP (plus nutrition education) to prevent infections, improve feeding and ultimately to improve growth among LBW infants in Bangladesh.
Specific Objectives Although the applicants clearly understand that the primary purpose of the Alive and Thrive RFP is to improve infant feeding, we believe that by preventing infections, feeding will improve and growth will accelerate. Thus our primary objective is to determine the relative effect of intervention packages to improve feeding and thus prevent or reverse linear growth faltering and reduce rates of stunting among LBW infants (Ha: Combination of all three interventions will improve feeding and prevent or reverse linear growth faltering and reduce rates of stunting)
Secondary objectives (i) Investigate the effect of intervention packages on rates of diarrhea and acute respiratory tract infection (ARI).
(Ha: Combination of all three interventions will reduce on rates of diarrhea and acute respiratory tract infection) (ii) Explore the effect of the intervention packages on energy and nutrient intakes of infants and their feeding behaviors.
(Ha: Combination of all three interventions will increase energy and nutrient intakes of infants and improve the feeding behaviors) (iii) Determine the impact of the improved MNP on iron status (hemoglobin level in blood) in a subgroup.
(Ha: The group receiving the improved MNP will have increased hemoglobin level in blood and reduced rates of anemia)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hand hygiene with Hand Sanitizer (HS) | Experimental | Other: Hand SanitizerTo obtain 480 low birth weight infants the entire area of Kaliganj and Norsinghdi will be divided into 48 clusters based on the list of pregnant women identified through a household survey. 24 clusters will be randomized to receive Hand Sanitizer plus nutrition and hygiene education and the remaining 24 will receive only nutrition and hygiene education. |
| Hand hygiene with no Hand Sanitizer | Experimental | Other: Hand Sanitizer, Dietary Supplement: Improved Micronutrient PowderTo obtain 480 low birth weight infants the entire area of Kaliganj and Norsinghdi will be divided into 48 clusters based on the list of pregnant women identified through a household survey. 24 clusters will be randomized to receive Hand Sanitizer plus nutrition and hygiene education and the remaining 24 will receive only nutrition and hygiene education. |
| Micronutrient Powder | Experimental | Dietary Supplement: Improved Micronutrient Powder, Dietary Supplement: No Micronutrient PowderFrom 6 months of age, children in randomized clusters will be assigned to receive one sachet of Improved Micronutrient Powder, I-MNP per day for six months with or without hand sanitizer. Throughout the entire intervention period, mothers/caregivers of the children in all groups will receive simple, standardized, and age and culturally appropriate nutrition and health education that aims to improve feeding and health-seeking behavior and caring practices. |
| Control | Placebo comparator | Other: No hand sanitizer, Dietary Supplement: No Micronutrient PowderFrom 6 months of age, children in randomized clusters will be assigned to receive no hand sanitizer or no micronutrient powder Throughout the entire intervention period, mothers/caregivers of the children in all groups will receive simple, standardized, and age and culturally appropriate nutrition and health education that aims to improve feeding and health-seeking behavior and caring practices. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- infants born as singletons and full term (mothers will be identified at ~8 months or >37 weeks gestation to avoid including premature babies who are at high risk of neonatal mortality).
- must have a birth weight ≥1800g and <2500g.
- Families involved in the study must be planning to remain in the study community for the next 12 months
- written consent must be received from an authorized guardian.
- all pregnant women will be identified and visited during their 8th month of pregnancy. A local informant will be identified for birth notification, who will inform the CHW (with a cell phone) when a child is born. All newborns will be screened and those who meet the inclusion criteria will be enrolled.
Key exclusion criteria (2 listed)
- newborns with severe illnesses or congenital abnormalities /severe malformations that affect feeding will be excluded from the study.
- infants whose mothers did not survive during childbirth will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand SanitizerThe water-based hand sanitizer to be used in the current project will be produced in India by Hexagon Inc. It will be dispensed via a foam dispenser, since it has been established that foam is preferable to gel because of the natural tendency to rub foam more thoroughly into one's hands. | Other | Hand hygiene with Hand Sanitizer (HS), Hand hygiene with no Hand Sanitizer |
| Improved Micronutrient PowderAlso: MNPA modified and improved formulation of MNPs will be used. The composition is specially designed to enhance appetite and growth with 17 essential micronutrients; including calcium and magnesium, as well as an increased amount of zinc (10 mg). Previously MNP formulations (including the UNICEF formulation) contained only 5 mg of zinc and did not contain magnesium and calcium, which are essential nutrients for bone formation. | Dietary supplement | Hand hygiene with no Hand Sanitizer, Micronutrient Powder |
| No hand sanitizerAll family members will receive hand-hygiene education with Information, Education and Communication (IEC) materials including pictorial messages describing critical points for hand-hygiene. No placebo for the hand sanitizers will be provided to families in Groups 3 and 4 because it would be unethical if families were to use an inactive hand-hygiene product as a substitute for routine hand-washing. Nevertheless, all groups will be instructed | Other | Control |
| No Micronutrient PowderI-MNP and placebo will be procured from a local pharmaceutical company in Dhaka, Bangladesh (Renata Pharma Ltd.). The outer-packaging of the sachets of 'I-MNP' and 'placebo-MNP' will be identical except for a different numeric code for each. | Dietary supplement | Control, Micronutrient Powder |
Primary outcome
Anthropometry - Recumbent Length
Time frame: Change from baseline in length over 12 months
Recumbent length will be measured to 0.01cm on a locally constructed wooden stadiometer. Anthropometric data will be converted to Z-scores using the WHO growth standards.
Anthropometry - Weight
Time frame: Change from baseline in weight over 12 months
weight using an infant balance with 15 g precision (SECA Model 345) calibrated on a regular, scheduled basis. Anthropometric data will be converted to Z-scores using the WHO growth standards.
5 secondary outcomes
Infectious Morbidity
Time frame: Weekly for 52 weeks
Infant and young child feeding
Time frame: Monthly for 12 months
Blood collection and Hemoglobin (Hb) measurement
Time frame: 6 and 12 months post randomization
Socioeconomic status (SES) and demographic information
Time frame: Baseline
Household Food Security
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Derived from this study: PubMed 27053383Shafique S, Sellen DW, Lou W, Jalal CS, Jolly SP, Zlotkin SH. Mineral- and vitamin-enhanced micronutrient powder reduces stunting in full-term low-birth-weight infants receiving nutrition, health, and hygiene education: a 2 x 2 factorial, cluster-randomized trial in Bangladesh. Am J Clin Nutr. 2016 May;103(5):1357-69. doi: 10.3945/ajcn.115.117770. Epub 2016 Apr 6.
- Derived from this study: PubMed 25143374Singla DR, Shafique S, Zlotkin SH, Aboud FE. A 22-element micronutrient powder benefits language but not cognition in Bangladeshi full-term low-birth-weight children. J Nutr. 2014 Nov;144(11):1803-10. doi: 10.3945/jn.114.193094. Epub 2014 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley Zlotkin, MD principal investigator
The Hospital for Sick Children
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hand Sanitizer, Improved Micronutrient Powder and No hand sanitizer in people with Infant, Low Birth Weight, run by The Hospital for Sick Children at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometry - Recumbent Length (time frame: Change from baseline in length over 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01455636, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2015.