Low BirthweightPhase 4ENATNCT04171388

Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia

A Phase 4 study testing Azithromycin 500 mg, Multiple Micronutrient or Fortified Balanced Energy Protein Supplement and Enhanced Infection Management Package (EIMP) in people with Low Birthweight and Preterm Birth, run by Brigham and Women's Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Low Birthweight, Preterm Birth, Maternal; Malnutrition, Affecting Fetus
What is being tested?: Azithromycin 500 mg, Multiple Micronutrient or Fortified Balanced Energy Protein Supplement and Enhanced Infection Management Package (EIMP)
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Mar 2020to 30 Nov 2021
Phase: Phase 4
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
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Pregnant women <=24 weeks gestation with a viable pregnancy based on a best clinical algorithm (LMP and/or symphysis fundal height)

Who cannot join

Pregnant women presenting at enrollment >24 weeks
Pregnant women presenting with non-viable fetus
Women who do not intend to deliver in the study catchment area
Known allergy to Azithromycin or macrolide antibiotic
Women who refuse to provide consent

About this study

Official title: Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Amhara Region, Ethiopia

The ENAT study will test the impact of packages of antenatal interventions to enhance maternal nutrition and manage pregnancy infections on the outcomes of infant birth size, gestational length, and infant growth in the first 6 months of life. Approximately 5,280 pregnant women will be enrolled into the study from 12 health centers in the Amhara region of Ethiopia. Routine antenatal care will be strengthened in all health centers, and six health centers will be randomized to additionally provide a nutritional intervention including daily multiple-micronutrient or a fortified balanced-energy protein supplement for malnourished women. Women across all 12 health centers will be individually randomized to receive one of three infection management interventions in pregnancy: 1) enhanced infection management package (screening-treatment for urinary tract infections and sexually transmitted infections, presumptive deworming); 2) presumptive azithromycin (2g at <24 wks and a second dose at least 4 weeks later); or 3) placebo. The women and their infants will be followed until 6 months postpartum. Outcomes of interest include birth size (weight, length), gestational age, maternal weight gain in pregnancy, maternal anemia, antimicrobial resistance, and infant size at 6 months.

Conditions: Low Birthweight, Preterm Birth, Maternal; Malnutrition, Affecting Fetus, Sexually Transmitted Diseases, Urinary Tract Infections, Pregnancy and Infectious Disease
Being tested: Azithromycin 500 mg, Multiple Micronutrient or Fortified Balanced Energy Protein Supplement, Placebo oral tablet 500 mg, Enhanced Infection Management Package (EIMP)
Keywords: Low birthweight, Preterm birth, Maternal nutrition, Small for gestational age, Chlamydia, Gonorrhea, Urinary tract infection, Presumptive antibiotics
Medical subject headings: Premature Birth, Malnutrition, Sexually Transmitted Diseases, Urinary Tract Infections, Communicable Diseases, Chlamydia Infections, Gonorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azithromycin 500 mgDrug
Azithromycin 500mg (Kern Pharma): 2g (4 tablets) at 2 time points during pregnancy: enrollment (<=24 weeks gestation), and follow-up ANC at least 4 weeks later
Multiple Micronutrient or Fortified Balanced Energy Protein SupplementDietary supplement
Daily multiple micronutrient (MMN) tablet (Contract Pharmacal Corp) for women with mid-upper arm circumference (MUAC) >=23 cm, OR Daily fortified balanced energy protein (BEP) supplement (DSM South Africa; Faffa Food Products): Fortified corn-soy blend (784 kcal/day) for women with MUAC <23 cm
Placebo oral tablet 500 mgDrug
Placebo 500mg (Idifarma): 2g (4 tablets) at 2 time points during pregnancy; enrollment (<24 weeks gestation), and follow up ANC at least 4 weeks later
Enhanced Infection Management Package (EIMP)Other
ENROLLMENT VISIT: Screening for bacteriuria with urine culture, and antimicrobial susceptibility testing; Screening for chlamydia and gonorrhea with Cepheid GeneXpert; Presumptive deworming with albendazole 500mg.
FOLLOWUP TREATMENT VISIT: For women with identified urinary tract infection or asymptomatic bacteriuria, treatment with antibiotics based on antimicrobial susceptibility patterns. For women with identified chlamydia or gonorrhea, treatment of woman (and partner) with appropriate antibiotics. Test of cure sample and retreatment of infection.
Second deworming with albendazole at least 4 weeks after enrollment ANC visit.

Study groups in NCT04171388
Study group	Role	What they receive
Routine care: Placebo	Placebo comparator	In all pregnancies presenting at all centers, routine antenatal care will be strengthened: * Provision of iron-folic acid and tetanus toxoid vaccine * Screening for anemia and blood pressure * Screening/treatment of HIV, syphilis, malaria, tuberculosis Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. Receives: Drug: Placebo oral tablet 500 mg
Routine care: Azithromycin	Experimental	Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. Receives: Drug: Azithromycin 500 mg
Routine care: Enhanced Infection Management Package (EIMP)	Experimental	At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrhea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment. Receives: Other: Enhanced Infection Management Package (EIMP)
Enhanced Nutrition Package (ENP): Placebo	Experimental	Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. Receives: Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement; Drug: Placebo oral tablet 500 mg
ENP: Azithromycin	Experimental	Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later. Receives: Drug: Azithromycin 500 mg; Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement
ENP: EIMP	Experimental	Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrohea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment. Receives: Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement; Other: Enhanced Infection Management Package (EIMP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Birth weight
Mean infant weight (g) among live born infants measured <72 hour of delivery
Measured: Within 72 hours of birth
Birth length
Mean infant length (cm) among live born infants measured <72 hours of delivery
Measured: Within 72 hours of birth

Secondary outcomes (10)

Gestational age
Mean gestational age at delivery
Measured: Birth
Preterm birth
Proportion of pregnancies resulting in spontaneous birth <37 weeks gestation among all births
Measured: Birth
Small-for-gestational age (SGA)
Proportions of newborns born SGA (<10% birthweight for gestational age and sex) among live born infants whose birthweight if measured within 72 hours of delivery.
Measured: within 72 hours of birth
Low birthweight
Proportion of newborns born with weight <2500 g among liveborn infants whose weight is measured within 72 hours of delivery
Measured: within 72 hours of birth
Length-for-age
Mean Length-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards (WHO 2006)
Measured: Birth, 6 months
Weight-for-age
Mean Weight-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards (WHO 2006)
Measured: Birth, 6 months
Rate of weight gain in pregnancy
Maternal weight gain (kg) per week gestation in the 2nd and 3rd trimester
Measured: From date of first 2nd trimester antenatal care (ANC) visit until date of last ANC visit before birth, assessed up to 6 months
Maternal anemia
Mean hemoglobin concentration
Measured: Third trimester antenatal care visit (28-40 weeks gestation)
Stillbirth
Rate of stillbirths per 1000 births
Measured: Birth
Prevalence of nasopharyngeal macrolide resistance in mothers-infants
Prevalence of nasopharyngeal macrolide resistance among S. pneumoniae isolates in mothers-infants at 1 and 6 months postpartum
Measured: 1 and 6 months post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202030 Nov 2021

First posted20 Nov 2019
Study start1 Mar 2020 (estimated)
Primary completion28 May 2021 (estimated)
Study completion30 Nov 2021 (estimated)

Why it stopped: Trial withdrawn due to COVID-19.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low BirthweightStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: 2x3 factorial randomized controlled trial, with cluster randomization of nutrition interventions and individually randomized infection management interventions
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04171388
Sponsor's protocol ID: 2018P002479
Acronym: ENAT
Status last verified: Aug 2020
First submitted: 9 Oct 2019
Last updated: 17 Aug 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Low Birthweight trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Amhara Region, Ethiopia
ClinicalTrials.gov ID: NCT04171388
Acronym / sponsor ID: ENAT / 2018P002479
Conditions: Low Birthweight, Preterm Birth, Maternal; Malnutrition, Affecting Fetus, Sexually Transmitted Diseases, Urinary Tract Infections, Pregnancy and Infectious Disease
Keywords: Low birthweight, Preterm birth, Maternal nutrition, Small for gestational age, Chlamydia, Gonorrhea, Urinary tract infection, Presumptive antibiotics
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Trial withdrawn due to COVID-19.
Enrolment: 0 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Addis Continental Institute of Public Health, Johns Hopkins Bloomberg School of Public Health, Boston Children's Hospital, Beth Israel Deaconess Medical Center, Harvard School of Public Health (HSPH), Amhara Public Health Institute, Jhpiego
Study start: 1 Mar 2020 (estimated)
Primary completion: 28 May 2021 (estimated)
Study completion: 30 Nov 2021 (estimated)
First posted: 20 Nov 2019 (actual)
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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: 2x3 factorial randomized controlled trial, with cluster randomization of nutrition interventions and individually randomized infection management interventions

Arm	Type	Receives
Routine care: Placebo	Placebo comparator	Drug: Placebo oral tablet 500 mgIn all pregnancies presenting at all centers, routine antenatal care will be strengthened: * Provision of iron-folic acid and tetanus toxoid vaccine * Screening for anemia and blood pressure * Screening/treatment of HIV, syphilis, malaria, tuberculosis Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.
Routine care: Azithromycin	Experimental	Drug: Azithromycin 500 mgAzithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.
Routine care: Enhanced Infection Management Package (EIMP)	Experimental	Other: Enhanced Infection Management Package (EIMP)At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrhea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment.
Enhanced Nutrition Package (ENP): Placebo	Experimental	Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement, Drug: Placebo oral tablet 500 mgPregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.
ENP: Azithromycin	Experimental	Drug: Azithromycin 500 mg, Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein SupplementPregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.
ENP: EIMP	Experimental	Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement, Other: Enhanced Infection Management Package (EIMP)Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrohea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment.

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Pregnant women <=24 weeks gestation with a viable pregnancy based on a best clinical algorithm (LMP and/or symphysis fundal height)

Key exclusion criteria (5 listed)

Pregnant women presenting at enrollment >24 weeks
Pregnant women presenting with non-viable fetus
Women who do not intend to deliver in the study catchment area
Known allergy to Azithromycin or macrolide antibiotic
Women who refuse to provide consent

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
Azithromycin 500 mgAzithromycin 500mg (Kern Pharma): 2g (4 tablets) at 2 time points during pregnancy: enrollment (<=24 weeks gestation), and follow-up ANC at least 4 weeks later	Drug	ENP: Azithromycin, Routine care: Azithromycin
Multiple Micronutrient or Fortified Balanced Energy Protein SupplementDaily multiple micronutrient (MMN) tablet (Contract Pharmacal Corp) for women with mid-upper arm circumference (MUAC) >=23 cm, OR Daily fortified balanced energy protein (BEP) supplement (DSM South Africa; Faffa Food Products): Fortified corn-soy blend (784 kcal/day) for women with MUAC <23 cm	Dietary supplement	ENP: Azithromycin, ENP: EIMP, Enhanced Nutrition Package (ENP): Placebo
Placebo oral tablet 500 mgPlacebo 500mg (Idifarma): 2g (4 tablets) at 2 time points during pregnancy; enrollment (<24 weeks gestation), and follow up ANC at least 4 weeks later	Drug	Enhanced Nutrition Package (ENP): Placebo, Routine care: Placebo
Enhanced Infection Management Package (EIMP)ENROLLMENT VISIT: Screening for bacteriuria with urine culture, and antimicrobial susceptibility testing; Screening for chlamydia and gonorrhea with Cepheid GeneXpert; Presumptive deworming with albendazole 500mg. FOLLOWUP TREATMENT VISIT: For women with identified urinary tract infection or asymptomatic bacteriuria, treatment with antibiotics based on antimicrobial susceptibility patterns. For women with identified chlamydia or gonorrhea, treatment of woman (and partner) with appropriate antibiotics. Test of cure sample and retreatment of infection. Second deworming with albendazole at least 4 weeks after enrollment ANC visit.	Other	ENP: EIMP, Routine care: Enhanced Infection Management Package (EIMP)

Primary outcome

Birth weight
Time frame: Within 72 hours of birth
Mean infant weight (g) among live born infants measured <72 hour of delivery
Birth length
Time frame: Within 72 hours of birth
Mean infant length (cm) among live born infants measured <72 hours of delivery

10 secondary outcomes

Gestational age
Time frame: Birth
Preterm birth
Time frame: Birth
Small-for-gestational age (SGA)
Time frame: within 72 hours of birth
Low birthweight
Time frame: within 72 hours of birth
Length-for-age
Time frame: Birth, 6 months
Weight-for-age
Time frame: Birth, 6 months
Rate of weight gain in pregnancy
Time frame: From date of first 2nd trimester antenatal care (ANC) visit until date of last ANC visit before birth, assessed up to 6 months
Maternal anemia
Time frame: Third trimester antenatal care visit (28-40 weeks gestation)
Stillbirth
Time frame: Birth
Prevalence of nasopharyngeal macrolide resistance in mothers-infants
Time frame: 1 and 6 months post-partum

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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?

Birth weight (time frame: Within 72 hours of birth). 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 NCT04171388.

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 17 Aug 2020.