Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial
Brief Summary: Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of these deaths are attributable to prematurity and infection. With the increasing rate of premature births in some settings, the mortality rate of over 50% among preterm babies in some of the developing countries require inexpensive hospital-based strategies to prevent fatal infections in newborns of these countries. As most of the deaths in preterm neonates are attributable to their vulnerability of infection, a potential low cost intervention like topical emollient therapy can be effectively directed to reduce infection related mortality and morbidity in the developing countries. Topical emollient therapy reduces the rate of infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss consequently conserving heat and energy to promote growth.

The broad goal of the study is to improve the survival rate of hospitalized preterm neonates in the developing countries by decreasing the incidence of infection using low-cost interventions.

HYPOTHESIS:

It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day of life in hospitalized preterm neonates reduces the incidence proportion of hospital acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it is hypothesized that the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18 more as compared to the weight gain in the routine skin care group.


Options:
A: Arm Label: Balneum oil bath; Type: EXPERIMENTAL; Interventions: Other: Balneum oil bath | Arm Label: standard skin cleanser; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Balneum oil bath; Assigned to Arm(s): Balneum oil bath
B: Arm Label: Observation only; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Food intervention; Type: EXPERIMENTAL; Interventions: Other: Food intervention | Arm Label: Skin care; Type: EXPERIMENTAL; Interventions: Other: Skin care | Arm Label: Food intervention and skin care; Type: EXPERIMENTAL; Interventions: Other: Food intervention, Other: Skin care | Intervention Type: OTHER; Name: Food intervention; Assigned to Arm(s): Food intervention, Food intervention and skin care | Intervention Type: OTHER; Name: Skin care; Assigned to Arm(s): Food intervention and skin care, Skin care
C: Arm Label: Daily Emollient; Type: EXPERIMENTAL; Interventions: Other: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream | Arm Label: Natural Skin; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream; Assigned to Arm(s): Daily Emollient
D: Arm Label: Topical Emollient; Type: EXPERIMENTAL; Interventions: Other: Topical Emollient | Arm Label: Routine Skin Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Topical Emollient; Assigned to Arm(s): Topical Emollient

Answer: D