Nursing CareNCT01236599
Thermoregulation in the Preterm Infant
A study testing Polyethylene for thermoregulation in the preterm infant in people with Nursing Care, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The purpose of this study is to compare the response of temperature adaptation in preterm infant using the polyethylene wrap with and without previous drying. Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Nursing Care
- What is being tested?
- Polyethylene for thermoregulation in the preterm infant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2009to Jun 2010
- 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 28 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995)
Who cannot join
- Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General de Zona N 4. Instituto Mexicano del Seguro Social
Celaya, Guanajuato, 38060
About this study
Official title: Comparison of Polyethylene Wrap With and Without Previous Drying in Preterm Infants: A Randomized Clinical Trial.
The purpose of this study is to compare the response of temperature adaptation in preterm infant using the polyethylene wrap with and without previous drying.
Read the detailed description
Preterm infants (PI) are predisposed to loss heat and have little subcutaneous tissue and a high ratio between surface and body weight and a reduced amount of glycogen deposits and brown fat (Gomella, 2005, p. 43).
In Mexico and South America in 2003 were reported 207.753 neonatal deaths, 21.4 per every 1,000 born alive in whom hypothermia was significant among infants with low birth weight and preterm infants. (Zuleta, Gomez \& Jaramillo, 2009).
PRETERM INFANT Official Mexican Norm -007-SSA2-1993 (1995) considers a preterm infant as the product of the conception from 28-37 weeks of gestation, and weighing 1000-2499 g.
THERMOREGULATION OF PRETERM INFANT Survival of the newborn increases if the excessive loss heat is prevented. To achieve this purpose the newborn should be kept in a thermal environment neutral "which is what allows an infant consume the least amount of energy to maintain normal body temperature". (Karlsen, 2006, p. 49) The heat is gained or lost by convection 37% (between a child and a fluid: air stream or during bathing), conduction 4% (between two bodies in contact with different temperatures: the fields, mattress) radiation, 43% (between two solid surfaces that are not in touch: cool walls of the incubator) and 16% evaporation (heat loss in the conversion of water from liquid to gas, skin, breathing, sweating). (Tamez \& Pantoja, 2004, pp. 29-30; Ruíz, 2007) The understanding of these forms of heat exchange provides the scientific basis for nursing interventions aimed at modifying the environment.
Response to cold stress of preterm infant: When the sensors of central and peripheral temperature detect stress for cold, they send signals to the hypothalamus. The hypothalamus activates the liberation of norepinephrine. This hormone causes increment in the metabolism, which increases the oxygen consumption and glucose utilization. The increment in the consumption of oxygen can induce hypoxemia and if it is severe, could progress to hypoxia. Peripheral vasoconstriction is limited in infant of very low birth weight in the first 48 hours of life; this increases the heat loss to level of the skin. In the preterm infant the loss heat occurs faster than its ability to produce and conserve heat. (Karlsen, 2006, p. 56) Adverse effects of cold stress in term and preterm neonate: When a term or a preterm neonate is hypothermic, the metabolism, oxygen consumption and glucose utilization increase. If the neonate, is experiencing trouble for breath, he will not be able of confront the increment in the demand of oxygen for tissues. This allows or increases the hypoxemia, which contributes to increased pulmonary vasoconstriction. The severe hypoxemia can progress to hypoxia, which leads to anaerobic metabolism. During anaerobic metabolism, the accumulation of lactic acid and blood ph drops is observed. If it is not reversed, the risk of death is high. (Jasso, 2005, p. 91; Karlsen, 2006, p. 58) The hypothermia can cause hypoglycemia, since the glucose is the primary source energy for the brain. The level of conscience of the neonate can diminish, the respiration can become slow and oxygenation will be affected. The survivors to an event of hypothermia have collateral effects as the increase of the difficulty of respiration, severe renal failure, disseminated coagulation, increase in the incidence of infection and persistence of the arterial conduit. (Karlsen, 2006, p. 58) PLACEMENT OF POLYETHYLENE BAG The program STABLE (sugar, temperature, airway, blood pressure, lab work and emotional support) for care post-resuscitation and pre-transport of sick neonates, recommended cover to premature infant with a plastic cover immediately after birth, from the neck down to reduce heat loss through evaporation and convection. (Karlsen, 2006, pp. 51, 53) The polyethylene bag, "is a cheap device, practical, simple, does not interfere with the immediate care or resuscitation (Vohra et al., 2004) and does not put in risk the integrity and security of the newborn. But it is not clear whether its effectiveness is similar with or without prior drying of the newborn, because the only study comparing these two techniques was conducted in term infants and it was not randomized (Menesses et al., 2002).
It is recommended that all apnea at birth should be treated as a secondary apnea and not delays resuscitation. (American Academy of Pediatrics and American Heart Association, 2000) At this stage every second is vital for the newborn, and from this comes the concern of knowing if the polyethylene bag is equally effective for thermoregulation of the newborn, with or without pre-drying, since it would save a few seconds for drying, and immediately beginning neonatal resuscitation.
- Conditions
- Nursing Care
- Being tested
- Polyethylene for thermoregulation in the preterm infant
- Keywords
- preterm infant, thermoregulation, polyethylene bag
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene for thermoregulation in the preterm infantOther
Also called Heart loss in the preterm infant
3 groups with 30 preterm infants (PI) each one: 1) PI under radiant warmer, drying, wrapped in sterile field preheated (traditional care), 2) PI under radiant warmer, wrapped in polyethylene bag after drying, with their naked face and access to umbilical catheters or venous access, and 3) PI under radiant warmer, without drying, wrapped in polyethylene bag, with their naked face and access to umbilical catheters or venous access. Body temperature (BT) and incubator temperature (IT) were measured every 15 minutes from birth until 120 minutes of extra uterine life.
| Study group | Role | What they receive |
|---|---|---|
| traditional care | No intervention | Preterm Infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off and wrapped up in a sterile preheated field Receives: Other: Polyethylene for thermoregulation in the preterm infant |
| Polyethylene bag with previous drying | Experimental | infants were placed under the radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off, and wrapped up in a polyethylene bag, leaving their faces discovered as well as the access at umbilical catheters or veined access. Receives: Other: Polyethylene for thermoregulation in the preterm infant |
| Polyethylene bag without previous drying | Experimental | Preterm infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel) and without previous body drying (only the head was dried), were wrapped up with the polyethylene bag, leaving their faces discovered as well as the access to umbilical catheters or veined access Receives: Other: Polyethylene for thermoregulation in the preterm infant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corporal temperature of preterm infants and Temperature of the incubator.
Corporal temperature. An axillary thermometer of mercury was used, which was placed in the boy's armpit, making sure that it was in contact with the skin, during five minutes.
Temperature of the incubator. It was directly registered from the incubator thermometer (medix TR 306). All the incubators started with a temperature of 34oC, and they were adjusted according to the necessity of preterm infant, when valuing the axillary temperature.
Measured: every 15 minutes until the two hours of extrauterine life
Secondary outcomes (8)
Gestational age
, the children from 28 to 37 weeks of gestational age that fulfilled the other inclusion approaches continued in the study. The Capurro's score considers five somatic data: nipple formation, skin texture, ear forms, breast nodule and plantar skin creases. First a partial punctuation was obtained considering each parameter, then the following formula was applied: (204 + partial punctuation) / 7 = gestational age
Measured: . It was valued at birth by Capurro's score
Weight
. It was measured at birth with the PI naked using mechanical weighing machine
Measured: It was valued at birth
Apgar score
Each one of the five identifiable characteristics with easiness was valued: muscle tone, heart rate, reflex irritability, skin coloration, breathing rate and effort, and each factor was scored on a scale of zero to two, the total punctuation, was determined with base in the sum of the five components
Measured: the minute and the five minutes of life
Heart rate
using a stethoscope with a neonatal bell (Riester model luxe duplexR Marks) during 15 seconds, the result was multiplied for four, to obtain the heart frequency in one minute.
Measured: It was valued at birth and every 15 minutes until the two hours of extrauterine life
Breathing frequency
The thoracic movements were observed during 30 seconds, considering the complete breathing cycle (inspiration and expiration). The obtained result was multiplied for two, to obtain the breathing frequency in one minute.
Measured: . It was valued at birth and every 15 minutes until the two hours of extrauterine life.
Capillar glucose
with the Optium Xceed monitor using ribbons of glucose test in blood (MediSense Optium).
Measured: . It was measured at birth and at two hours of extrauterine life
Environmental temperature
in the delivery room with an environmental thermometer (RadioShackR)
Measured: It was registered at birth
Blood pressure
. It was valued by the flushing technique with a sphygmomanometer (Riester marks). The sphygmomanometer cuff was applied to the wrist or ankle and the distal portion of the extremity was compressed by firmly wrapping a wide, soft rubber drain around it, beginning at the tips of the digits and working proximally to the cuff edge. The manometer was rapidly inflated to 80 mmHg and the elastic wrapping removed. With gradual release of the pressure, a point was reached at which there was a distinct blush of the blanched portion of the extremity.
Measured: . It was measured at 15 minutes, one hour and two hours of extrauterine life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nursing CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Investigators
- Norma Amador, PhD, Study director, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236599
- Sponsor's protocol ID
- LMCT-01
- Status last verified
- Nov 2010
- First submitted
- 5 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duman N, Utkutan S, Kumral A, Koroglu TF, Ozkan H. Polyethylene skin wrapping accelerates recovery from hypothermia in very low-birthweight infants. Pediatr Int. 2006 Feb;48(1):29-32. doi: 10.1111/j.1442-200X.2006.02155.x.
PubMed 16490066Lenclen R, Mazraani M, Jugie M, Couderc S, Hoenn E, Carbajal R, Blanc P, Paupe A. [Use of a polyethylene bag: a way to improve the thermal environment of the premature newborn at the delivery room]. Arch Pediatr. 2002 Mar;9(3):238-44. doi: 10.1016/s0929-693x(01)00759-x. French.
PubMed 11938534Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.
PubMed 15580195
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Polyethylene Wrap With and Without Previous Drying in Preterm Infants: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01236599
- Acronym / sponsor ID
- LMCT-01
- Conditions
- Nursing Care
- Keywords
- preterm infant, thermoregulation, polyethylene bag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the response of temperature adaptation in preterm infant using the polyethylene wrap with and without previous drying.
Detailed description
Preterm infants (PI) are predisposed to loss heat and have little subcutaneous tissue and a high ratio between surface and body weight and a reduced amount of glycogen deposits and brown fat (Gomella, 2005, p. 43).
In Mexico and South America in 2003 were reported 207.753 neonatal deaths, 21.4 per every 1,000 born alive in whom hypothermia was significant among infants with low birth weight and preterm infants. (Zuleta, Gomez \& Jaramillo, 2009).
PRETERM INFANT Official Mexican Norm -007-SSA2-1993 (1995) considers a preterm infant as the product of the conception from 28-37 weeks of gestation, and weighing 1000-2499 g.
THERMOREGULATION OF PRETERM INFANT Survival of the newborn increases if the excessive loss heat is prevented. To achieve this purpose the newborn should be kept in a thermal environment neutral "which is what allows an infant consume the least amount of energy to maintain normal body temperature". (Karlsen, 2006, p. 49) The heat is gained or lost by convection 37% (between a child and a fluid: air stream or during bathing), conduction 4% (between two bodies in contact with different temperatures: the fields, mattress) radiation, 43% (between two solid surfaces that are not in touch: cool walls of the incubator) and 16% evaporation (heat loss in the conversion of water from liquid to gas, skin, breathing, sweating). (Tamez \& Pantoja, 2004, pp. 29-30; Ruíz, 2007) The understanding of these forms of heat exchange provides the scientific basis for nursing interventions aimed at modifying the environment.
Response to cold stress of preterm infant: When the sensors of central and peripheral temperature detect stress for cold, they send signals to the hypothalamus. The hypothalamus activates the liberation of norepinephrine. This hormone causes increment in the metabolism, which increases the oxygen consumption and glucose utilization. The increment in the consumption of oxygen can induce hypoxemia and if it is severe, could progress to hypoxia. Peripheral vasoconstriction is limited in infant of very low birth weight in the first 48 hours of life; this increases the heat loss to level of the skin. In the preterm infant the loss heat occurs faster than its ability to produce and conserve heat. (Karlsen, 2006, p. 56) Adverse effects of cold stress in term and preterm neonate: When a term or a preterm neonate is hypothermic, the metabolism, oxygen consumption and glucose utilization increase. If the neonate, is experiencing trouble for breath, he will not be able of confront the increment in the demand of oxygen for tissues. This allows or increases the hypoxemia, which contributes to increased pulmonary vasoconstriction. The severe hypoxemia can progress to hypoxia, which leads to anaerobic metabolism. During anaerobic metabolism, the accumulation of lactic acid and blood ph drops is observed. If it is not reversed, the risk of death is high. (Jasso, 2005, p. 91; Karlsen, 2006, p. 58) The hypothermia can cause hypoglycemia, since the glucose is the primary source energy for the brain. The level of conscience of the neonate can diminish, the respiration can become slow and oxygenation will be affected. The survivors to an event of hypothermia have collateral effects as the increase of the difficulty of respiration, severe renal failure, disseminated coagulation, increase in the incidence of infection and persistence of the arterial conduit. (Karlsen, 2006, p. 58) PLACEMENT OF POLYETHYLENE BAG The program STABLE (sugar, temperature, airway, blood pressure, lab work and emotional support) for care post-resuscitation and pre-transport of sick neonates, recommended cover to premature infant with a plastic cover immediately after birth, from the neck down to reduce heat loss through evaporation and convection. (Karlsen, 2006, pp. 51, 53) The polyethylene bag, "is a cheap device, practical, simple, does not interfere with the immediate care or resuscitation (Vohra et al., 2004) and does not put in risk the integrity and security of the newborn. But it is not clear whether its effectiveness is similar with or without prior drying of the newborn, because the only study comparing these two techniques was conducted in term infants and it was not randomized (Menesses et al., 2002).
It is recommended that all apnea at birth should be treated as a secondary apnea and not delays resuscitation. (American Academy of Pediatrics and American Heart Association, 2000) At this stage every second is vital for the newborn, and from this comes the concern of knowing if the polyethylene bag is equally effective for thermoregulation of the newborn, with or without pre-drying, since it would save a few seconds for drying, and immediately beginning neonatal resuscitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| traditional care | No intervention | Other: Polyethylene for thermoregulation in the preterm infantPreterm Infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off and wrapped up in a sterile preheated field |
| Polyethylene bag with previous drying | Experimental | Other: Polyethylene for thermoregulation in the preterm infantinfants were placed under the radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off, and wrapped up in a polyethylene bag, leaving their faces discovered as well as the access at umbilical catheters or veined access. |
| Polyethylene bag without previous drying | Experimental | Other: Polyethylene for thermoregulation in the preterm infantPreterm infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel) and without previous body drying (only the head was dried), were wrapped up with the polyethylene bag, leaving their faces discovered as well as the access to umbilical catheters or veined access |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995)
Key exclusion criteria (1 listed)
- Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene for thermoregulation in the preterm infantAlso: Heart loss in the preterm infant3 groups with 30 preterm infants (PI) each one: 1) PI under radiant warmer, drying, wrapped in sterile field preheated (traditional care), 2) PI under radiant warmer, wrapped in polyethylene bag after drying, with their naked face and access to umbilical catheters or venous access, and 3) PI under radiant warmer, without drying, wrapped in polyethylene bag, with their naked face and access to umbilical catheters or venous access. Body temperature (BT) and incubator temperature (IT) were measured every 15 minutes from birth until 120 minutes of extra uterine life. | Other | Polyethylene bag with previous drying, Polyethylene bag without previous drying, traditional care |
Primary outcome
Corporal temperature of preterm infants and Temperature of the incubator.
Time frame: every 15 minutes until the two hours of extrauterine life
Corporal temperature. An axillary thermometer of mercury was used, which was placed in the boy's armpit, making sure that it was in contact with the skin, during five minutes. Temperature of the incubator. It was directly registered from the incubator thermometer (medix TR 306). All the incubators started with a temperature of 34oC, and they were adjusted according to the necessity of preterm infant, when valuing the axillary temperature.
8 secondary outcomes
Gestational age
Time frame: . It was valued at birth by Capurro's score
Weight
Time frame: It was valued at birth
Apgar score
Time frame: the minute and the five minutes of life
Heart rate
Time frame: It was valued at birth and every 15 minutes until the two hours of extrauterine life
Breathing frequency
Time frame: . It was valued at birth and every 15 minutes until the two hours of extrauterine life.
Capillar glucose
Time frame: . It was measured at birth and at two hours of extrauterine life
Environmental temperature
Time frame: It was registered at birth
Blood pressure
Time frame: . It was measured at 15 minutes, one hour and two hours of extrauterine life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 16490066Duman N, Utkutan S, Kumral A, Koroglu TF, Ozkan H. Polyethylene skin wrapping accelerates recovery from hypothermia in very low-birthweight infants. Pediatr Int. 2006 Feb;48(1):29-32. doi: 10.1111/j.1442-200X.2006.02155.x.
- Background: PubMed 11938534Lenclen R, Mazraani M, Jugie M, Couderc S, Hoenn E, Carbajal R, Blanc P, Paupe A. [Use of a polyethylene bag: a way to improve the thermal environment of the premature newborn at the delivery room]. Arch Pediatr. 2002 Mar;9(3):238-44. doi: 10.1016/s0929-693x(01)00759-x. French.
- Background: PubMed 15580195Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norma Amador, PhD study director
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene for thermoregulation in the preterm infant in people with Nursing Care, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Nov 2010. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corporal temperature of preterm infants and Temperature of the incubator. (time frame: every 15 minutes until the two hours of extrauterine life). 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 NCT01236599, which also lists 3 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 9 Nov 2010.