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Very Low Birth Weight InfantNCT05461404

Emollient Therapy for Premature Infants in Zimbabwe

A study testing Topical Emollient Therapy in people with Very Low Birth Weight Infant, run by Stanford University at 1 site in Zimbabwe.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates. Read more about this study

Who is it for?
Ages Up to 28 daysHealthy volunteers can take part
Conditions the study is for
Very Low Birth Weight Infant
What is being tested?
Topical Emollient Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
1 siteZimbabwe
Study dates
1 Aug 2023to 31 Dec 2025
Phase
Interventional
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 Up to 28 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • infants <72 hours of age
  • weigh 700-1500 at birth
  • hospitalized at SMCH

Who cannot join

  • infants who are moribund and highly likely not to survive despite any intervention
  • significant breaches in their skin barrier
  • conditions indicating failure to gain weight
  • critically ill (definition below):
  • Oxygen saturation <88% on oxygen therapy AND ≥2 of the following conditions:
  • respiratory rate <20 or >100 breaths per minute
Show all 12Show fewer
  • apnea requiring bag-mask ventilation
  • heart rate <100 or >200 beats per minute
  • congenital syphilis
  • hydrops fetalis
  • a life-threatening congenital anomaly or major surgical condition requiring intervention
  • generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function

Trial locations and contacts

1 site in 1 country.

Gary Darmstadt, MD, MS contact

650-724-6014

gdarmsta@stanford.edu

Zimbabwe1 site

  • Sally Mugabe Central Hospital (SMCH)

    Harare

    Hilda A Mujuru, MBChB, MMed, MSc

Other trials in Zimbabwe

About this study

Official title: Emollient Therapy for Improved Survival and Growth of Very Low Birth Weight Infants in Zimbabwe

The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates.

Read the detailed description

For infants whose parent/caretaker provides written informed consent, the study nurse coordinator on-site will allocate infants to one of two strata (700- <1000 g or 1000-1500 g). Participants within each stratum will be randomly assigned in a 1:1 ratio to one of two treatment groups: 1) high-linoleate SSO, or 2) standard-of-care treatment without use of topical emollients or massage.

Being tested
Topical Emollient Therapy
Keywords
emollient therapy, sunflower seed oil (SSO), skin barrier, Zimbabwe, neonatal mortality, newborn care, preterm infants, postnatal care, growth

What participants receive

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

  • Topical Emollient TherapyOther

    Application of high-linoleate (>60% linoleic acid) SSO to the epidermis.

Study groups in NCT05461404
Study groupRoleWhat they receive
Emollient armExperimentalInfants will receive gentle, hygienic whole-body massage by trained nurses (not parents or other family members) with 3g of SSO per kg of body weight - a dose sufficient to saturate the skin - three times daily for the first 14 days and twice daily thereafter during the duration of their stay in the hospital until death, discharge or through day 28 after birth.
Receives: Other: Topical Emollient Therapy
Control armNo interventionInfants in the control group will receive the standard of care for infants in the neonatal care unit, which does not include use of topical emollients or massage (i.e., family members will not be allowed to apply skin care products to their infants), or other particular measures to prevent skin breakdown or to modulate skin barrier function.

What is being measured

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

  1. Compare mortality rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days

    This will be an intent-to-treat analysis, using the randomization level rather than the received level of intervention.

    To estimate the change in mortality rate, we will use a maximum likelihood approach, operationalized as a logistic model with fixed effects for study arm and strata random effects.

    Measured: Baseline and 28 days

Secondary outcomes (1)

  1. Compare growth rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days.

    For the secondary analysis of change in growth rate, the quantity of interest is change in weight over the study period as a proportion of the infant's birthweight (g/kg/day). This secondary analysis will use a maximum likelihood approach to both testing and estimation, operationalized as a linear model with fixed effects for the study arm and strata.

    Measured: Baseline and 28 days

Timeline

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

  1. First posted18 Jul 2022
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Infants will be enrolled after informed consent, stratified by birthweight (700- \<1000 g, 1000-1500 g) and randomly allocated 1:1 to the two arms of the trial which will be run in parallel.
Masking
None (open label)
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05461404
Sponsor's protocol ID
66546
Status last verified
Apr 2023
First submitted
13 Jul 2022
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fischer N, Darmstadt GL, Shahunja KM, Crowther JM, Kendall L, Gibson RA, Ahmed T, Relman DA. Topical emollient therapy with sunflower seed oil alters the skin microbiota of young children with severe acute malnutrition in Bangladesh: A randomised, controlled study. J Glob Health. 2021 Jul 17;11:04047. doi: 10.7189/jogh.11.04047. eCollection 2021.

    PubMed 34386216

  • Darmstadt GL, Mao-Qiang M, Chi E, Saha SK, Ziboh VA, Black RE, Santosham M, Elias PM. Impact of topical oils on the skin barrier: possible implications for neonatal health in developing countries. Acta Paediatr. 2002;91(5):546-54. doi: 10.1080/080352502753711678.

    PubMed 12113324

  • Cleminson J, McGuire W. Topical emollient for preventing infection in preterm infants. Cochrane Database Syst Rev. 2021 May 7;5(5):CD001150. doi: 10.1002/14651858.CD001150.pub4.

    PubMed 33961715

  • Elias PM, Brown BE, Ziboh VA. The permeability barrier in essential fatty acid deficiency: evidence for a direct role for linoleic acid in barrier function. J Invest Dermatol. 1980 Apr;74(4):230-3. doi: 10.1111/1523-1747.ep12541775.

    PubMed 7373078

  • Prottey C, Hartop PJ, Black JG, McCormack JI. The repair of impaired epidermal barrier function in rats by the cutaneous application of linoleic acid. Br J Dermatol. 1976 Jan;94(1):13-21. doi: 10.1111/j.1365-2133.1976.tb04336.x.

    PubMed 1252336

  • Darmstadt GL, Badrawi N, Law PA, Ahmed S, Bashir M, Iskander I, Al Said D, El Kholy A, Husein MH, Alam A, Winch PJ, Gipson R, Santosham M. Topically applied sunflower seed oil prevents invasive bacterial infections in preterm infants in Egypt: a randomized, controlled clinical trial. Pediatr Infect Dis J. 2004 Aug;23(8):719-25. doi: 10.1097/01.inf.0000133047.50836.6f.

    PubMed 15295221

  • Kumar V, Kumar A, Mishra S, Kan P, Ashraf S, Singh S, Blanks KJH, Baiocchi M, Limcaoco M, Ghosh AK, Kumar A, Krishna R, Stevenson DK, Tian L, Darmstadt GL; Shivgarh Emollient Research Group. Effects of emollient therapy with sunflower seed oil on neonatal growth and morbidity in Uttar Pradesh, India: a cluster-randomized, open-label, controlled trial. Am J Clin Nutr. 2022 Apr 1;115(4):1092-1104. doi: 10.1093/ajcn/nqab430.

    PubMed 34982820

  • Darmstadt GL, Saha SK, Ahmed AS, Chowdhury MA, Law PA, Ahmed S, Alam MA, Black RE, Santosham M. Effect of topical treatment with skin barrier-enhancing emollients on nosocomial infections in preterm infants in Bangladesh: a randomised controlled trial. Lancet. 2005 Mar 19-25;365(9464):1039-45. doi: 10.1016/S0140-6736(05)71140-5.

    PubMed 15781099

  • Darmstadt GL, Saha SK, Ahmed AS, Ahmed S, Chowdhury MA, Law PA, Rosenberg RE, Black RE, Santosham M. Effect of skin barrier therapy on neonatal mortality rates in preterm infants in Bangladesh: a randomized, controlled, clinical trial. Pediatrics. 2008 Mar;121(3):522-9. doi: 10.1542/peds.2007-0213.

    PubMed 18310201

  • Salam RA, Darmstadt GL, Bhutta ZA. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30.

    PubMed 25637007

  • Salam RA, Das JK, Darmstadt GL, Bhutta ZA. Emollient therapy for preterm newborn infants--evidence from the developing world. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S31. doi: 10.1186/1471-2458-13-S3-S31. Epub 2013 Dec 20.

    PubMed 24564550

  • Kumar A, Mishra S, Singh S, Ashraf S, Kan P, Ghosh AK, Kumar A, Krishna R, Stevenson DK, Tian L, Elias PM, Darmstadt GL, Kumar V; Shivgarh Emollient Research Group. Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial. PLoS Med. 2021 Sep 28;18(9):e1003680. doi: 10.1371/journal.pmed.1003680. eCollection 2021 Sep.

    PubMed 34582448

  • Hui A, Chimhini G, Saungweme M, Kaisi D, Munetsi E, Mujuru HA, Darmstadt GL. Postnatal care and acceptability of emollient therapy in very low birthweight infants in Harare, Zimbabwe: a qualitative analysis. BMC Pediatr. 2024 Mar 16;24(1):187. doi: 10.1186/s12887-024-04661-x.

    PubMed 38493088

Questions about this trial

What is this clinical trial studying?

A study testing Topical Emollient Therapy in people with Very Low Birth Weight Infant, run by Stanford University at 1 site in Zimbabwe.

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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zimbabwe. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gary Darmstadt, MD, MS (650-724-6014, gdarmsta@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare mortality rates for VLBW infants treated with SSO vs. control while hospitalized for up to 28 completed days (time frame: Baseline and 28 days). 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 NCT05461404, which also lists 13 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 19 Apr 2023.

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