Emollient Therapy for Premature Infants in Zimbabwe

Stanford University

Status: Not yet enrolling

Conditions: Very Low Birth Weight Infant

Treatments: Other: Topical Emollient Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05461404

66546

Details and patient eligibility

About

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

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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):

  1. Oxygen saturation <88% on oxygen therapy AND ≥2 of the following conditions:
  2. respiratory rate <20 or >100 breaths per minute
  3. apnea requiring bag-mask ventilation
  4. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 2 patient groups

Emollient arm

Experimental group

Description:

Infants 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.

Treatment:

Other: Topical Emollient Therapy

Control arm

No Intervention group

Description:

Infants 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.