ZamCAT: Zambia Chlorhexidine Application Trial

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01241318
• Collaborator: Bill and Melinda Gates Foundation (Other), Ministry of Health, Zambia (Other), Zambia Center for Applied Health Research and Development (Other)
• Enrollment: 77,535
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 2502.6

Study Details

Study Description

Brief Summary

This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Drug: Chlorhexidine gluconate (4%); Procedure: Dry cord care	Phase 2/Phase 3

Detailed Description

The primary goals of the Zambia Chlorhexidine Application Trial (ZamCAT) are to assess whether daily 4% chlorhexidine cord cleansing is more effective than dry cord care for the prevention of neonatal deaths and omphalitis (umbilical cord infection) in Southern Province, Zambia. Secondary goals are to 1) compare where pregnant women plan to deliver and where they actually deliver, and 2) to describe the health services network available to pregnant and postpartum women in case of serious illness among the women and their newborn infants.

Clusters consisting of individual health centers and their respective catchment areas will be assigned to one of two arms. In the intervention clusters, mothers will apply 4% chlorhexidine to their infants daily until 3 days after the cord completely separates. Mothers in the control clusters will use dry cord care as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.

In order to achieve the 4th Millennium Development Goal of reducing child mortality by two-thirds, simple, inexpensive, and scalable interventions are required. If the use of a 4% chlorhexidine umbilical cord wash effectively reduces neonatal mortality, this will be a low-cost intervention that can be easily translated from a research project into a program for countrywide implementation in Zambia. These results will also add to the limited evidence base about the effectiveness of interventions for reduction of neonatal mortality in sub-Saharan Africa.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77535 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chlorhexidine cord care Mothers located in health facility catchment areas assigned to this arm will apply Chlorhexidine gluconate (4%) to their infants daily until three days after the cord completely separates. Bottles of chlorhexidine is provided to women during antenatal care.	Drug: Chlorhexidine gluconate (4%); Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.; Other Names: topical antiseptic
Active Comparator: Dry cord care Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.	Procedure: Dry cord care; Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.

Outcome Measures

Primary Outcome Measures

1. All-cause Neonatal Mortality [28 days post-partum]

   All-cause neonatal mortality based on vital status at 28 days post-partum

2. All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life [28 days post-partum]

   All-cause mortality by day 28 of life among newborns who survive at least the first day of life

Secondary Outcome Measures

1. Incidence of Omphalitis [28 days postpartum]

   Omphalitis, or umbilical cord infection, defined as: presence of umbilical cord pus and mild, moderate or severe redness moderate or severe redness without the presence of umbilical cord pus

2. Place of Delivery [28 days postpartum]

   The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.

3. Factors Influencing Delivery Location [28 days postpartum]

   Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)

4. Health Facility Characteristics [12 months after study initiation]

   Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant women in the 2nd or 3rd trimester

• Age 15 years and above

• Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum

• Willingness to provide cord care as per the protocol of their cluster

• Willingness to provide informed consent

Exclusion Criteria:

• Pregnant women who are not willing to provide cord care as per the protocol of their cluster

• Pregnant women who are not willing to provide informed consent

• Pregnant women in the 1st trimester

• Pregnant women under age 15 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Facilities throughout Southern Province	Choma	Southern Province	Zambia

Sponsors and Collaborators

• Boston University
• Bill and Melinda Gates Foundation
• Ministry of Health, Zambia
• Zambia Center for Applied Health Research and Development

Investigators

• Principal Investigator: Davidson H Hamer, MD, Boston University Center for Global Health and Development
• Principal Investigator: Katherine Semrau, PhD, Boston University Center for Global Health and Development

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.
• Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8.
• Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67.
• Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8.

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT01241318
• Other Study ID Numbers: H-29647
• First Posted: Nov 16, 2010
• Last Update Posted: Aug 31, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Boston University: neonate; omphalitis; neonatal mortality; maternal health; umbilical cord infection
• Additional relevant MeSH terms: Chlorhexidine; Chlorhexidine gluconate

Study Results

Participant Flow

Recruitment Details	In the 90 clusters (i.e. government-run health facilities), pregnant women who met eligibility criteria attending antenatal care were offered enrollment. Recruitment started February 15, 2011 and ended January 30, 2013.
Pre-assignment Detail	Mothers were enrolled in the study while pregnant and infants were enrolled after delivery; thus the total protocol enrollment is women + infants. Study reporting is completed at the woman level and thus the total enrolled is listed at the woman level in the outcomes tables.

Arm/Group Title	Chlorhexidine Cord Care	Dry Cord Care
Arm/Group Description	Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.	Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
Period Title: Overall Study
STARTED	19629	20050
Liveborn Infant	18510	19346
COMPLETED	18450	19308
NOT COMPLETED	1179	742

Baseline Characteristics

Arm/Group Title	Chlorhexidine Cord Care	Dry Cord Care	Total
Arm/Group Description	Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.	Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.	Total of all reporting groups
Overall Participants	19629	20050	39679
Age, Customized (participants) [Number]
<20 years	4671 23.8%	4580 22.8%	9251 23.3%
20-35 years	12772 65.1%	13122 65.4%	25894 65.3%
>35 years	2012 10.3%	2194 10.9%	4206 10.6%
Missing (not recorded)	174 0.9%	154 0.8%	328 0.8%
Sex: Female, Male (Count of Participants)
Female	19629 100%	20050 100%	39679 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Tonga	17003 86.6%	17650 88%	34653 87.3%
Ila	105 0.5%	121 0.6%	226 0.6%
Lozi	786 4%	795 4%	1581 4%
Nyanja	525 2.7%	432 2.2%	957 2.4%
Bemba	413 2.1%	433 2.2%	846 2.1%
Other	629 3.2%	481 2.4%	1110 2.8%
Missing (not recorded)	168 0.9%	138 0.7%	306 0.8%
Region of Enrollment (participants) [Number]
Zambia	19629 100%	20050 100%	39679 100%
Maternal Education (participants) [Number]
No eduction	1936 9.9%	1958 9.8%	3894 9.8%
Lower Primary	2293 11.7%	2563 12.8%	4856 12.2%
Upper Primary	7731 39.4%	7874 39.3%	15605 39.3%
Junior Secondary	5422 27.6%	5499 27.4%	10921 27.5%
Upper Secondary	1895 9.7%	1840 9.2%	3735 9.4%
>Upper Secondary	180 0.9%	160 0.8%	340 0.9%
Do not know	3 0%	10 0%	13 0%
Missing (not recorded)	169 0.9%	146 0.7%	315 0.8%
Marital Status (participants) [Number]
Single	3021 15.4%	3133 15.6%	6154 15.5%
Married	16107 82.1%	16499 82.3%	32606 82.2%
Separated, divorced or widowed	224 1.1%	187 0.9%	411 1%
Cohabiting	109 0.6%	89 0.4%	198 0.5%
Missing (not recorded)	168 0.9%	142 0.7%	310 0.8%
Maternal literacy (participants) [Number]
Not at all	5037 25.7%	5491 27.4%	10528 26.5%
A bit	8835 45%	9516 47.5%	18351 46.2%
Very well	5492 28%	4835 24.1%	10327 26%
No response from mother	77 0.4%	61 0.3%	138 0.3%
Missing (not recorded)	188 1%	147 0.7%	335 0.8%
Household water source (participants) [Number]
Household tap	1861 9.5%	1715 8.6%	3576 9%
Community tap	1919 9.8%	1761 8.8%	3680 9.3%
Other water source on own property	2295 11.7%	2403 12%	4698 11.8%
Community well or river	13241 67.5%	13768 68.7%	27009 68.1%
No answer from Mother	56 0.3%	62 0.3%	118 0.3%
Other	67 0.3%	166 0.8%	233 0.6%
Missing (Not recorded)	190 1%	175 0.9%	365 0.9%
Parity (pregnancies) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pregnancies]	2.4 (2.3)	2.5 (2.4)	2.5 (2.4)
Gravida (deliveries) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [deliveries]	3.5 (2.3)	3.6 (2.4)	3.6 (2.4)
Gestational Age at enrollment (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	28.0 (7.2)	28.4 (7.2)	28.3 (7.2)
Slept under mosquito bednet the previous night (participants) [Number]
Yes	11092 56.5%	11783 58.8%	22875 57.7%
No	8310 42.3%	8075 40.3%	16385 41.3%
Missing (not recorded)	227 1.2%	192 1%	419 1.1%

Outcome Measures

1. Primary Outcome

Title	All-cause Neonatal Mortality
Description	All-cause neonatal mortality based on vital status at 28 days post-partum
Time Frame	28 days post-partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chlorhexidine Cord Care	Dry Cord Care
Arm/Group Description	Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.	Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
Measure Participants	18450	19308
Neonatal mortality	282 1.4%	263 1.3%
Survived to day 28	18168 92.6%	19045 95%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chlorhexidine Cord Care, Dry Cord Care
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments	The chlorhexidine arm is the numerator and dry cord care arm is the denominator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.

2. Primary Outcome

Title	All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life
Description	All-cause mortality by day 28 of life among newborns who survive at least the first day of life
Time Frame	28 days post-partum

Outcome Measure Data

Analysis Population Description

All liveborn neonates who survived the first 24 hours after delivery

Arm/Group Title	Chlorhexidine Cord Care	Dry Cord Care
Arm/Group Description	Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.	Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
Measure Participants	18424	19266
Neonatal mortality	200	186
Survived to day 28	18224	19080

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chlorhexidine Cord Care, Dry Cord Care
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.47
	Parameter Dispersion	Type: Value:
	Estimation Comments	Generalized estimating equation models adjusting for cluster-randomized design were used.

3. Secondary Outcome

Title	Incidence of Omphalitis
Description	Omphalitis, or umbilical cord infection, defined as: presence of umbilical cord pus and mild, moderate or severe redness moderate or severe redness without the presence of umbilical cord pus
Time Frame	28 days postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chlorhexidine Cord Care	Dry Cord Care
Arm/Group Description	Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.	Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
Measure Participants	18510	19346
Omphalitis	82	118
No omphalitis	18428	19228

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Chlorhexidine Cord Care, Dry Cord Care
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.47 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Generalized estimating equation models adjusting for cluster-randomized design were used.

4. Secondary Outcome

Title	Place of Delivery
Description	The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.
Time Frame	28 days postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chlorhexidine Cord Care	Dry Cord Care
Arm/Group Description	Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.	Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
Measure Participants	18510	19346
Home Delivery	6509 33.2%	6682 33.3%
Facility Delivery	11456 58.4%	12204 60.9%
Other	190 1%	128 0.6%
Missing	355 1.8%	332 1.7%

5. Secondary Outcome

Title	Factors Influencing Delivery Location
Description	Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)
Time Frame	28 days postpartum

Outcome Measure Data

Analysis Population Description

Women enrolled in the ZamCAT study and delivery location known. Please note these are different denominators reported as this analysis is not based on intervention randomization, but rather an analysis focused on women's location of childbirth. Therefore, the number of women included in this analysis is based on a subset of all women enrolled.

Arm/Group Title	Facility Delivery	Home Delivery
Arm/Group Description	Women who enrolled in ZamCAT study and delivered at a facility	Women who enrolled in ZamCAT study and delivered at home
Measure Participants	23815	13255
Same Location as Prior Delivery	3198 16.3%	2082 10.4%
Need for Skilled Attendance12991	12991 66.2%	5693 28.4%
Financial Constraints	1823 9.3%	1249 6.2%
Physical Distance	6345 32.3%	3930 19.6%
Relationship with Provider	572 2.9%	429 2.1%
Family/Social Expectations	1255 6.4%	990 4.9%
Safety for Mother/Baby	14129 72%	5911 29.5%
Other	1480 7.5%	803 4%
Missing	1364 6.9%	770 3.8%

6. Secondary Outcome

Title	Health Facility Characteristics
Description	Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities).
Time Frame	12 months after study initiation

Outcome Measure Data

Analysis Population Description

Health facilities

Arm/Group Title	Study Health Facilities & Hospitals
Arm/Group Description	90 health facilities and 10 district hospitals were included in the main chlorhexidine trial. A survey was completed to assess availability of emergency obstetric care.
Measure Participants	39679
Measure Health facilities	100
Basic emergency obstetrical and newborn care	6
No basic emergency obstetrical and newborn care	94

Adverse Events

Time Frame	Adverse event data were collected during the 1 month follow up period past delivery.
Adverse Event Reporting Description	Umbilical cord was observed by the field data collector at every visit (day 1, 4, 10, 28 post-partum). Adverse events were defined as ocular exposure to chlorhexidine, local skin irritation, accidental ingestion, contact dermatitis, or anaphylaxis.
Arm/Group Title	Chlorhexidine Cord Care		Dry Cord Care
Arm/Group Description	Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.		Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
All Cause Mortality
	Chlorhexidine Cord Care		Dry Cord Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	282/18510 (1.5%)		263/19346 (1.4%)
Serious Adverse Events
	Chlorhexidine Cord Care		Dry Cord Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18510 (0%)		0/19346 (0%)
Other (Not Including Serious) Adverse Events
	Chlorhexidine Cord Care		Dry Cord Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/18510 (0%)		0/19346 (0%)
Eye disorders
Chlorhexidine ocular exposure	1/18510 (0%)	1	0/19346 (0%)	0
Skin and subcutaneous tissue disorders
Chlorhexidine-related adverse events	8/18510 (0%)	8	0/19346 (0%)	0

Limitations/Caveats

Only 89% (37 856 of 42 570) of the target sample size was attained. When we completed a post-hoc power calculation with the obtained sample size and observed Neonatal Mortality Rate (NMR), we had 80% power to detect a 28% reduction in NMR.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.