The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants

NCT ID: NCT02052284

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-12-31

Brief Summary

Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area. Loss of fluids is associated with many complications. The investigators hypothesize that application of sterile water to the skin of these infants is associated with decreased fluid requirements in the first week of life , improve skin integrity and decrease some complications of prematurity.

Detailed Description

Extremely low birth weight (ELBW) infants have significant transepidermal water loss immediately after birth. This significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. Water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. In order to compensate for these losses, clinicians have to progressively increase fluid intake. Excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (PDA), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and mortality. Also skin integrity is important to protect against skin infection and secondary sepsis. Based on recent studies and relevant data, the risk of sepsis in ELBW is up to 40% nationwide, but only about 25% at GWUH Water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. The current practice at GWUH is to clean the bodies of premature infants using a piece of damp cloth with warm water. This is performed at birth and consequently every other days. The study group will receive more frequent and standardized applications. The investigators hypothesize that application of sterile water in ELBW infants is associated with decreased fluid requirements in the first week of life. As a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of BPD with no increased incidence of skin or systemic infections.

Conditions

Fluid Loss; Dehydration; Extreme Immaturity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

The control group will receive standard skin care of the NICU, which does not include specific measures to modulate skin-barrier function.The current practice at GWUH NICU is that nurses clean the bodies of newborns less than 1000 grams using a piece of damp cloth with warm water. This is performed at birth and consequently every other days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Water wash

The study group will undergo a protocol of sterile water application in addition to routine skin care of the NICU. The study group will receive more frequent and standardized applications. A commercially sterile water bottle (Enfamil® Water) will be kept inside the isolette, to be maintained at isolette temperature, and will be changed on a daily basis. Nurses use sterile gloves as a routine for care of ELBW infants. A 2 inches x 2 inches sterile gauze will be soaked in sterile water and gently applied to all skin of the baby excluding umbilical cord and IV lines sites. This procedure will be repeated every 4 hours with routine patient care for the first 1 week of life.

Group Type: EXPERIMENTAL

Sterile water application

Intervention Type: OTHER

Nurses are trained in proper dispensing and application of water in a sterile gentle way that will minimize shear force on the skin, risk for skin injury, and the potential for spread of fecal flora.

Interventions

Sterile water application

Nurses are trained in proper dispensing and application of water in a sterile gentle way that will minimize shear force on the skin, risk for skin injury, and the potential for spread of fecal flora.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Extremely Low Birth Weight (less than 1000 grams at birth), and

2. Less than 24 hours of life

Exclusion Criteria

1. Major congenital anomalies

2. Malformations or other surgical emergencies requiring immediate transfer.

3. Major skin abnormalities

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed ElDib

Assistant Professor of Pediatrics and of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed El-Dib, MD

Role: PRINCIPAL_INVESTIGATOR

The George Washington University

Locations

The George Washington University Hospital NICU

Washington D.C., District of Columbia, United States

Countries

United States

References

Baumgart S, Langman CB, Sosulski R, Fox WW, Polin RA. Fluid, electrolyte, and glucose maintenance in the very low birth weight infant. Clin Pediatr (Phila). 1982 Apr;21(4):199-206. doi: 10.1177/000992288202100401.

Reference Type: BACKGROUND

PMID: 7067312 (View on PubMed)

Afsar FS. Physiological skin conditions of preterm and term neonates. Clin Exp Dermatol. 2010 Jun;35(4):346-50. doi: 10.1111/j.1365-2230.2009.03562.x. Epub 2009 Sep 15.

Reference Type: BACKGROUND

PMID: 19758381 (View on PubMed)

Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000503. doi: 10.1002/14651858.CD000503.pub2.

Reference Type: BACKGROUND

PMID: 18253981 (View on PubMed)

Other Identifiers

071319

Identifier Type: -

Identifier Source: org_study_id